As a matter-of-fact, wrote WebMD, Thomas J. Moore, senior scientist for drug safety and policy at the Institute for Safe Medication Practices in Horsham, Pennsylvania said that Chantix has so much potential danger it should contain restrictions including exclusions for police, military, and others who must carry weapons. Moore is one of three others who co-wrote the new Chantix report just published in the journal, Annals of Pharmacotherapy, said WebMD.
"My colleagues and I have been concerned about the safety profile of [Chantix] since our first report [warning of adverse events] in 2008," Moore told WebMD.
We recently wrote that strong warnings were issued by Health Canada over Champix (in the U.S., the drug, generically known as varenicline tartrate, is called Chantix), which is sold by Pfizer Canada Inc., wrote The Globe and Mail. The warning was issued by Pfizer and federal health officials following concerns that the drug is linked to “mood changes; hostility; suicidal behavior and serious, sometimes fatal, skin reactions.” Champix, the Pfizer Canada, Inc. brand must carry a boxed warning, indicating a serious safety issue or serious issue with adverse events exists, said The Globe and Mail; the U.S. Food and Drug Administration (FDA) had earlier required a similar warning.
Approved in the U.S. by the FDA in 2006 as a treatment for smoking cessation, wrote WebMD, Chantix blocks nicotine by targeting the brain’s nicotine receptors. Treatment begins with a low dose that is incrementally increased while smokers can smoke into their eighth day, at which point, they must cease smoking, explained WebMD. Patients remain on the drug for 12 weeks and, sometimes, can be prescribed an additional 12 weeks of the drug.
About a year after being on the market, reports began emerging about patients exhibiting strange and dangerous behavior while on Chantix. For instance, a Dallas musician on Chantix was behaving aggressively and abusively and was killed while attempting to kick in the door of a girlfriend’s neighbor, the researchers wrote, said WebMD. The FDA has received a number of other adverse event reports and issued information on the potential risks, mandating a medication guide be provided to patients with each refill, wrote WebMD.
The authors of this recent study collected data on 78 adverse event reports received by the FDA, four cases reported in clinical trials, and three cases from published information, said WebMD. According to Moore, the 78 cases are just a drop in the bucket. Looking at 26 cases in particular, the authors found that “10 involved assault, nine involved homicidal thoughts, and seven … included other thoughts or acts of aggression or violence,” said WebMD.
In another sampling review, the authors found that at least four people expressed seriously aggressive behavior against themselves, loved ones, and strangers with symptoms tending to appear about two days after starting Chantix, said WebMD. Once stopped, the symptoms—for the most part—disappeared.
Previously, the FDA said psychiatric side effects seen among Chantix users included 98 reports of suicide and 188 reports of attempted suicide. While some reported psychiatric problems could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking. Also, as of recent data, Health Canada received over 1,200 reports of adverse reactions associated with Champix since its release in country in 2007, said The Globe and Mail.
The warning was issued by Pfizer and federal health officials following concerns that the popular smoking cessation drug is linked to “mood changes; hostility; suicidal behavior and serious, sometimes fatal, skin reactions.” Champix, the Pfizer Canada, Inc. brand must carry a boxed warning, indicating a serious safety issue or serious issue with adverse events exists, said The Globe and Mail; the U.S. Food and Drug Administration (FDA) required a similar warning since last year.
At that time, the FDA said psychiatric side effects seen among Chantix users included—at that time—98 reports of suicide and 188 reports of attempted suicide. While some reported psychiatric problems could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking.
Health Canada stated that Champix is a prescription medicine used in combination with supportive counseling to help motivated adults quit smoking and that patients experiencing any of the following events—or caretakers and families observing the following—should stop the treatment and immediately contact a healthcare provider:
• Changes in mood or behavior including depressed mood, agitation, aggression, hostility, thoughts of self-harm, or harm towards others.
• Serious allergic reactions, including swelling of the face, lips, gums, tongue and throat that can cause trouble breathing, as well as skin reactions, including rash, swelling, redness, and peeling of the skin. This includes hypersensitivity reactions, such as angioedema (swelling under the skin that can be fatal) and serious skin reactions, including Stevens-Johnson syndrome and erythema multiforme.
Health Canada also warned patients to be aware that neuropsychiatric side-effects have occurred in patients taking Champix, regardless if those patients did or did not have a history of psychiatric disorder; alcohol could increase these risks. Expanded side effects such as sleepiness, dizziness, loss of consciousness, seizures, or difficulty concentrating, were discussed as having been observed in Chantix users.
To date, Health Canada has received over 1,200 reports of adverse reactions associated with Champix since its release in country in 2007, said The Globe and Mail. The following June, the department issued a public advisory warning consumers about some reactions patients taking Champix experienced related to behavior changes, hostility, and suicidal ideation, said The Globe and Mail; a reminder was sent January 2009 and the department announced plans to place a stricter warning on the drug.
Pfizer has long maintained Chantix/Champix’s safety and argues that such effects are often seen when people attempt to quit smoking. According to Pierre Martineau, director of medical affairs of cardiovascular and metabolic at Pfizer Canada, “Nicotine withdrawal symptoms are something that can cause neuropsychiatric adverse events,” quote The Globe and Mail. While the controversy over the drug’s safety and efficacy continue, Chantix’s association with psychiatric problems has spawned scores of product liability lawsuits.
Albrecht's death occurred in September 2007, just a week after he began taking Chantix. Shortly after beginning Chantix therapy, Albrecht began complaining of vivid dreams. According to a Dallas Morning News article published after his death, Albrecht had lashed out violently towards his girlfriend on the night he died – something she said had never occurred before. Albrecht’s girlfriend told the Morning News that he seemed confused and terrified, and looked at her as though he did not recognize her. Somehow, Albrecht ended up at the home of a neighbor, banging violently on the back door. A call was made to 911, but before the police arrived the terrified neighbor had fired a warning shot from his rifle, which accidentally hit and killed Albrecht.
In their lawsuit, Albrecht's parents allege that their son's use of Chantix played a "direct and proximate" role in his death. According to the Dallas Observer, the Albrecht's are hoping that by filing the lawsuit, they will "remind Pfizer they have to keep the public informed of the risks associated with this drug."
Albrecht's parents also acknowledge that Pfizer's attorneys will likely make an issue of their son's alcohol use (his blood alcohol level was three times over the legal driving limit) on the night of his death. According to the Observer, they are ready for that fight, and want to see their lawsuit go to trial. They insist that Albrecht's death was the result of vivid dreams, hallucinations and behavioral changes that had been caused by Chantix.
In July, the Food & Drug Administration (FDA) mandated that its most serious safety warning - a Black Box - regarding psychiatric side effects be included on the Chantix label. According to The Washington Post, the FDA said psychiatric side effects seen among Chantix users included 98 reports of suicide and 188 reports of attempted suicide. While some of the psychiatric problems reported could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking.
Chantix's association with psychiatric problems has spawned scores of product liability lawsuits similar to the one filed by the Albrecht family. The U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for September 24 to determine whether all federal Chantix lawsuits should be consolidated and centralized in one district as a Multidistrict Litigation.
It should be of no surprise to readers of this blog that Chantix is getting such a serious safety warning, as its problems are well-documented. The FDA actually began investigating its link to psychiatric side effects in late 2007. In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a Black Box warning.
The FDA said today that new Black Box Warning for Chantix and Zyban was based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature. According to a report in The Washington Post, the FDA had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban.
In many cases, the FDA said the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped. The agency also said that some of the problems could have been the result of nicotine withdrawal, however many of the reported events occurred while patients were still smoking.
Zyban, manufactured by GlaxoSmithKline, was originally marketed as an antidepressant under the name Wellbutrin. In 1997, the FDA approved Zyban to be used as a quit smoking aid. In today's announcement, the FDA said similar information on mental health events will be required for Wellbutrin and its generic equivalents. These drugs already carry a Black Box Warning for suicidal behavior in treating psychiatric disorders.
The FDA said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. Patients should immediately contact their health care professional if they experience such changes.
The anti-smoking drug Chantix is among 20 medications currently undergoing a Food & Drug Administration (FDA) safety review. According to Reuters, Chantix was included on a list of such drugs released by the FDA yesterday. Other drugs on the list include Provigil, which is used to treat sleep disorders; the weight-loss drug orlistat; and Detrol, a drug used to treat overactive bladder.
The list, which the FDA issues on a quarterly basis, is part of the agency's ongoing effort to inform the public about early investigations of potential side effects that have been reported, Reuters said.
It should be of no surprise to readers of this blog that Chantix made the FDA's list, as its safety problems are well-documented. In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning - the agency’s highest safety alert.
The FDA is now reviewing Chantix for a possible association with accidental injury, vision impairment and other issues. According to Reuters, the Chantix review was prompted by reports of accidents, vision loss and other problems in hundreds of patients.
The FDA's latest safety review comes on the heels of a report published last year by the Institute for Safe Medicine Practices, which found that the FDA received 1001 reports of serious adverse events associated with Chantix in the first three months of 2008. According to the report, the only other drug that even came close to matching Chantix during the same period was heparin which was the subject of a recall earlier that year. According to the Institute, the Chantix side effect reports included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.
According to Reuters, other drugs on the list include:
* Orlistat (sold as the prescription drug Xenical, and over-the-counter as Alli) for a risk of liver injury;
* Nuvigil and Provigil for serious skin reactions that were identified as an issue with the drugs in 2007;
* Detrol for reports of Stevens-Johnson syndrome, a serious skin reaction;
* HIV drug, Sustiva due to one report of an eye-related birth defect;
* The contraceptive Yasmin, for a possible risk of pancreatitis.
The commercial focuses on a Website dedicated to smoking cessation entitled MyTimeToQuit.com and presents information in a public service format, says Consumer Reports, pointing out that it is only at the end of the commercial that hints about the ad’s origin are discreetly revealed. The ad indicates, in the final moments, that it is sponsored by Pfizer, which is the maker of Chantix. Also, the MyTimeToQuit Website leads viewers to the Chantix Website.
Consumer Reports notes that the methods, while “sneaky,” are legal and point to a trend in which such DTC ads are leaning more toward so-called “help-seeking” ads. These ads, says Consumer Reports, do not mention the drug being marketed, but, rather, discuss the treatment for which the drug is approved, sending viewers to a Website or toll-free telephone number. The next step—the initial Website or toll-free number—provides more information that includes learning about a “prescription treatment option.” Consumer Reports noted that www.FibroCenter.com and www.PsoriasisConnect.com are both such types of pharmaceutical industry-sponsored Websites that lead consumers to information on prescription drugs.
This emerging type of advertising is effective when industry is looking to market a medication that has extensive or dangerous side effects because if the drug’s name is not mentioned, the advertiser is not mandated to disclose its side effects, according to the U.S. Food and Drug Administration (FDA), said Consumer Reports.
Chantix, a smoking cessation medication marketed by Pfizer, Inc., was approved by the FDA in 2006. Chantix side effects may include suicidal thoughts, depression, and even violent behavior. In September 2007, Chantix side effects were implicated in the bizarre death of a Dallas, Texas man, among other horrible stories.
A number of adverse event reports were made to the FDA following Chantix’s release to the market such as “serious neuropsychiatric symptoms,” including “changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide” said Consumer Reports. The reactions prompted a drug label update last year to include warnings about potential psychiatric side effects associated with Chantix use.
One of the problems with the release of Chantix is that Pfizer conducted studies on the medication, but did not include people with a history of depression, bipolar disorder, or serious mental illness, all of which include heavy smokers and for whom Chantix might pose serious risks. Some believe, said Consumer Reports, that because Chantix affects some brain processes and because some high-risk groups were not included in testing, the adverse events were not revealed until after the drug received FDA approval.
Consumer Reports warns that when approached with public service-like advertising, to determine from where it is sponsored and be aware that if the information is sponsored by the pharmaceutical industry, the goal of the information is to sell drugs. Also, be aware of options on such sites requesting information on personal stories, which require patient release and enable release of the entire story for marketing purposes.
Chantix (sold as Champix in Canada) works by blocking nicotine receptors to the brain. When it was first introduced, Chantix was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. But the drug has been linked to disturbing side effects, including suicidal thoughts and behavior.
Last February, the U.S. Food & Drug Administration (FDA) said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
The Canadian Product Monograph for Chantix was first updated in December 2007 and again in May 2008 to reflect important safety information related to serious psychiatric side-effects. Yesterday, Health Canada said it was issuing its latest Chantix reminder because the New Year often prompts people to undertake anti-smoking efforts. The agency said anyone considering using Chantix should:
- Be aware of any unusual thoughts, feelings or behaviors, especially those related to depression, aggression or self-harm. Patients should stop the drug immediately if there are such concerns.
- Tell a doctor if they have experienced depression or other mental health problems before taking Chantix, as these symptoms may worsen while taking the drug.
- Avoid driving a car or operating hazardous machinery until they are reasonably certain that Chantix does not affect them adversely.
In the U.S. Chantix continues to be the subject of numerous side effect reports. Just this past October, a report issued by the non-profit Institute for Safe Medication Practices found that in the first quarter of 2008, the FDA received more serious side effect reports for Chantix than for any other medication. According to the Institute, the Chantix side effects reported in that time frame included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.
The BBC explains that Chantix is a nicotine-mimicking drug that enables the body to reduce its urge for cigarettes while also reducing its withdrawal symptoms. However, in studies, the drug did not provide increased efficacy over other methods of smoking cessation. Despite this, notes the BBC, Pfizer earned over $883 million from the drug in its first year.
In addition to not offering better results over other alternatives, Chantix has been associated with unusual and sometimes dangerous side effects. The BBC piece discussed a woman who attempted suicide days after beginning the drug and a man who succeeded in killing himself while on Champix. Interestingly, in the suicide case, the coroner was unable to rule the death a suicide because the drug was in the victim’s bloodstream and the physician was aware of its links to suicidal ideation, noted the BBC. In Britain, according to the piece, over 3,000 people have “complained about adverse reactions to Champix,” with nearly 200 reporting suicidal reactions, 16 attempting suicide and 10 succeeding in committing suicide.
The BBC investigation led to similar findings in the U.S. with one man creating a night-long scene of fighting with his girlfriend and with a handgun, causing an armed, police stand-off. All this occurred after the man, an Iraq vet with post-traumatic stress, had taken Chantix for only a few days. Veterans Affairs prescribed the drug as part of a study and, in that case, a Congressional investigation ensued in which the victim noted that the problem originated with Chantix, according to the BBC.
The BBC also discussed a father of three who killed himself with a shotgun to his mouth, another man who killed himself with a shot to the head, and a mother who hanged herself. All three were on the drug and none had prior psychiatric history.
As we recently reported, Chantix was linked to 10 suicides in the UK, based on information from that country’s health regulators, representing the first time officials at the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) revealed the link between Chantix and suicide there. Earlier this year, the U.S. Food & Drug Administration (FDA) said it linked 37 suicides to Chantix.
Meanwhile, MedPageToday.com, also reported that Chantix has been linked with over 1,000 adverse events that include 50 deaths, in the first quarter of this year alone. The Institute for Safe Medication Practices reported that this figure now places Chantix at the “top of its list of drugs associated with serious injuries during the quarter.”
Since its approval in 2006, Chantix has been associated with 3,325 reported serious injuries in this country that include 112 deaths, the institute said, according to MedPageToday.com. Because the FDA’s post-market surveillance system is voluntary, the report may be underestimating actual figures.
Chantix, approved in both the US and Britain in 2006, works by blocking nicotine receptors to the brain. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.
But the drug has been the subject of disturbing side effect reports. In November 2007, the FDA issued an “Early Communication” that stated its preliminary assessment revealed many reports of suicidal behavior it had received in relation to the drug reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
Just last month, a report issued by the non-profit Institute for Safe Medication Practices found that in the first quarter of 2008, the FDA received more serious side effect reports for Chantix than for any other medication. According to the Institute, the Chantix side effects reported in that time frame included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.
Earlier this year all pilots and air traffic controllers in the US were banned from taking Chantix because of fears about potential side effects.
In the UK, where Pfizer sells Chantix under the name Champix, the MHRA website says a total of 24 people taking the medication have died, and of those, 10 were suicides. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.
The MHRA also says the number of users reporting adverse side effects while using Chantix has doubled in the past seven months – up from 1,811 in February to 3,541 in September. The British health watchdog is now warning doctors and nurses to monitor the effects of the drug on smokers over the New Year, when many will try to kick the habit.
Last December, the European Medicines Agency ruled that the inserts in boxes of Chantix be updated to include warnings about suicide and depression.
According to the report issued Tuesday by the Institute for Safe Medicine Practices, the FDA received 1001 reports of serious adverse events associated with Chantix in the first three months of this year. The only other drug that even came close to matching Chantix during the same period was heparin (779 side effect reports, including 238 possible deaths), which was the subject of a drug contamination scandal earlier this year.
According to the Institute, the Chantix side effect reports included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.
This was the second report on Chantix side effects the Institute has issued this year. In May, researchers there reported that Chantix had been the subject of 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.
According to Reuters, the accident reports are being reviewed by the FDA. "FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate," an FDA spokesperson told Reuters via email.
The FDA has already reviewed Chantix for a possible link to suicide and suicidal behavior. In February, the agency asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
Following the May report from the Institute for Safe Medicine Practices, several government agencies, including the Department of Transportation, the Federal Aviation Administration and the Department of Defense issued rules restricting the use of Chantix.
Two drugs accounted for what the AP termed a “disproportionately large share of the latest reports.” One drug was heparin, the tainted blood thinner from China that caused an international safety scandal that, according to the ISMP study, accounted for 779 reports of serious problems, including 102 deaths. The FDA, which relies on data spanning a longer time frame, reports 238 deaths possibly linked to heparin.
The other drug was Chantix, a new anti-smoking drug from Pfizer that has been blamed for a number of unusual and dangerous reactions and works in the brain to both ease withdrawal symptoms and block the pleasurable effects of nicotine when a smoker attempts to light up. Chantix received the most reports of any medication. The FDA should forcefully warn patients taking Chantix that they might suffer blackouts and other problems that could lead to accidents, the report said. The report found 15 cases of traffic accidents, and 52 additional cases involving blackouts or loss of consciousness in Chantix patients; the FDA received 1,001 reports of serious injuries, possibly linked to Chantix, represnting more than for the ten best-selling brand name drugs combined.
Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. Meanwhile, we have long been reporting on the bizarre reactions Chantix users have been experiencing and, earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Although the government has banned Chantix for pilots, Pfizer said yesterday "We stand by the efficacy and safety profile of Chantix."
The FDA had no immediate response to the report, but defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy; its monitoring system relies on voluntary reports from doctors. Many believe the system only captures a small percentage of actual cases.
The report also stated that the 20,745 cases reported from January-March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, said the AP. Twenty-three percent—4,824—ended in death, a nearly three percent increase from the last calendar quarter of 2007. Previous ISMP research revealed that serious drug safety problems reported to the FDA increased significantly from 1998-2005.
“FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation,” reported the AP. For instance, if “the FDA were a police agency, the reports would indicate ‘probable cause,’ but not necessarily ‘guilt beyond a reasonable doubt,’” the AP pointed out. As far as Chantix is concerned, many feel that reasonable doubt has been met.
Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.
But the drug has been the subject of disturbing side effect reports. In the US, Chantix has been linked to suicides and attempted suicides. In November 2007, the FDA issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
Today's Institute for Safe Medication Practices report said that for the first three months of 2008, Chantix had been linked to 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.
This is not the first time that the Institute has taken aim at Chantix. In May, researchers there reported that Chantix had been the subject of 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.
After the May report was released, several government agencies, including the Department of Transportation, the Federal Aviation Administration and the Department of Defense all restricted the use of Chantix. Pilots and air-traffic controllers were told to stop using Chantix immediately.
This latest Institute report comes at a difficult time for Pfizer, the maker of Chantix, which has been trying to counter the drug's bad publicity. It was only last month that Pfizer resumed running new ads on TV that mention Chantix by name. The company had ceased such spots last year, as concerns over Chantix side effects mounted. Since then, sales of the drug have fallen off.
Pfizer is undoubtedly desperate to salvage Chantix, as it was counting on the drug to become one of its major growth drivers. Pfizer had touted Chantix as a product that could help offset $12 billion in sales that the company’s Lipitor cholesterol medicine will begin losing to generic competition in 2010.
In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.
Over the summer, ABC News, in conjunction with The Washington Times, aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with PTSD - had not been told that the drug was linked to depression, suicide and psychotic behavior. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA’s notice didn’t specifically mention suicide.
The ABC News/Washington Times report sparked an outcry, and Congress ordered the VA to conduct an internal review of the Chantix study. The review, which was released Friday by the VA's Office of Research Oversight (ORO), points out that Chantix was "newly approved by the FDA for smoking cessation when it became available for use by [the study's] participants, and it had not been formally evaluated in a comparable study population."
The review found that no system was in place to warn veterans when the FDA issues new warnings that drugs they are taking might cause serious side effects. Researchers responsible for the study first failed to notify internal review boards that oversaw the experiment when the FDA first publicized its concerns in November. When a second warning was issued in February, it took 16 to 134 days to alert veterans.
The review also found monitoring of the studies at 10 different sites to be an "unacceptable failure" and that review boards did not investigate some 26 "serious adverse events" that some participants experienced.
Despite the problems with VA Chantix study, it is still ongoing. As of Feb. 1, when the FDA issued its warning, 120 participants were still taking Chantix. All except 27 have signed an addendum referencing the newest warnings and nine have dropped out of the study, the VA said.
Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Some analysts had estimated that Chantix sales could reach $2.28 billion by 2012.
But the drug has been the subject of disturbing side effect reports. In the US, Chantix has been linked to dozens of suicides and hundreds of attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
In May, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.
According to Forbes.com, the new Chantix ads, which begin running on Sunday, feature the same "tortoise and the hare" theme Pfizer used before it stopped advertising the drug. The longer spots now run for 90 seconds, and roughly 41 seconds involve side effect information. About half of that time is devoted to warning that patients taking Chantix should stop taking it if they experience agitation, suicidal thoughts or suicidal behavior. Pfizer says the role of Chantix in those symptoms is "not known."
It is not unusual for drug makers to rework ads after a safety controversy has erupted. While one expert interviewed by Forbes said she was glad the new Chantix ads will include specific side effect information, she is withholding judgment until she actually sees the spot. "It is good news if the serious risks are now present physically," Ruth Day, of Medical Cognition Laboratory at Duke University, said. "But are they there functionally--in a way that people will understand and remember them?"
Anyone who watches television has seen Pfizer's ad for Chantix, although they might not know it. In the spot, a middle-age woman tells the camera, "At 6:30 in the morning, I have a cigarette. And then another on my way to work." Viewers are then directed to Mytimetoquit.com, where they can receive information on smoking cessation. Visitors to the site find a link to a Chantix site that contains information on the antismoking drug, including the negative side effects.
Pfizer is not alone in using this type of advertising. SonofiAventis has been running a compelling TV spot that leads viewers to a Web site called silenceyourrooster.com. The site promotes Ambien, a sleeping aid sold by the company.
Drug companies like these ads because the Food & Drug Administration (FDA) does not require that they list safety information like side effects. Advertisements that mention a medication by name must include the reading of possible side effect. Drug company marketing execs claim that reading off side effects takes up too much time in an expensive 30 or 60 second spot. But when a drug is the subject of safety concerns, these rules can make unbranded advertising an even more attractive option for pharmaceutical companies.
According to The Wall Street Journal, Pfizer first aired the "My Time to Quit" ads in 2006, shortly after it came on the market. But as Chantix sales rose, the company started running ads that mentioned the drug by name, and dropped the unbranded campaign.
That only changed a few months ago. Pfizer resurrected "My Time to Quit" in June, after concerns were raised over Chantix side effects. The move came after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.
The Institute's report followed two FDA safety alerts - one in November 2007 and another in February 2008 - that warned Chantix had been associated with suicidal thoughts and other psychiatric side effects. At the time of the February alert, the FDA asked Pfizer to elevate the prominence of safety information regarding such side effects to the warnings and precautions section of the Chantix prescribing information, or labeling.
Some consumer advocates believe that leaving out safety information misleads consumers. Drug companies counter that they are only trying to increase awareness of a disease or treatment, not push a particular medication. The increasing use of unbranded drug ads will doubtless fuel the debate, and that could get the attention of lawmakers. Bob Ehrlich of DTC Perspectives, which monitors direct to consumer advertising by drug makers, told The Wall Street Journal that while the ads are clever, "There's a risk they could rouse congressional ire over cute commercials that don't emphasize medicine."
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
The decision to remove Chantix from the pharmacy at the Yokata Air Base was made after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.
The report noted that in the fourth quarter of 2007, Chantix accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.
Two days after the institute’s report, the Defense Department’s Office of the Chief Medical Officer recommended that Chantix "should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members."
According to the "Stars and Stripes" website, no Chantix patients at Yakota have reported any adverse reactions. A patient with approval from his doctor can opt to continue the medication, and special order the drug. In the meantime, Yokota has suspended all refills of Chantix until patients review with their health care provider the potential risks and benefits of continuing the drug.
Since Chantix was approved by the FDA in 2006, the number of military prescriptions for the drug has exploded. In 2006, only 262 Chantix prescription were written at U.S. military medical facilities. By 2007, that number had jumped to 67,580,
The Thorax paper, entitled, "Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation: Results from a Randomised Open-Label Trial," reports on a 52-week study--the first-ever direct comparison of the NicoDerm CQ Clear Patch to Chantix. The study used an “open-label” design. In other words, subjects knew the medications they were taking. "This study confirms that there is no magic bullet when it comes to smoking cessation and that both therapeutic nicotine and Chantix (varenicline tartrate) demonstrate long-term effectiveness," stated Dr. Howard Marsh, vice president of Worldwide Medical Affairs for Glaxo Consumer Healthcare. "There is also no single approach that will work for everyone. For example, a substantial proportion of quit attempts are made spontaneously, without much planning. Therapeutic nicotine is widely available without the need for a prescription or a visit to a doctor's office."
Although each smoking cessation medicine was proven effective, in separate double blind placebo-controlled studies for NicoDerm CQ and Chantix, NicoDerm saw a 45 percent success rate, versus 18 percent for placebo, following the end of a 10-week treatment; Chantix saw a 44 percent success rate versus 18 percent for placebo following 12-week treatment.
The NicoDerm CQ patch and other TN products help reduce nicotine withdrawal symptoms, including nicotine craving, associated with quitting smoking by allowing smokers to wean off nicotine gradually. Chantix marketed by and approved by the Food & Drug Administration (FDA) in 2006, has been linked to side effects that may include suicidal thoughts, depression, and even violent behavior. In September 2007, Chantix side effects were implicated in the bizarre death of a Dallas, Texas man.
The Chantix label warns of a variety of other side effects, including nausea, changes in dreaming, constipation, flatulence, and vomiting. But those warnings are more prominent and easier to find than the fine print on the package insert that warns of the possibility of psychotic and suicidal behavior. Since its approval, increasing numbers of Chantix users have reported these terrifying side effects.
Chantix works by blocking nicotine receptors, thereby reducing cravings for and decreases the pleasurable effects of cigarettes and other tobacco products. Chantix is the first such nicotine receptor partial agonist approved by the FDA and is seen an alternative to other smoking cessation drugs and nicotine replacement therapy.
The lawsuit alleges that Pfizer purposely excluded people with a history of mental illness when it tested Chantix during clinical trials. ”I run a clinic, and two out of three (smokers) I see have psychiatric or mood problems,” Dr. Daniel Seidman, director of Smoking Cessation Services at Columbia University Medical Center, is quoted in the suit. The suit also alleges the active ingredient in Chantix was derived from cytosine. Cytosine has been linked to suicide and the suit alleges Pfizer should have known about that link based on documentation dating back over 30 years. The suit also alleges Pfizer historically delays publication of scientific papers if such papers contain results unfavorable to the marketing of its products. The Institute for Safe Medication Practices recently reported that it has received notice of nearly 1,000 serious side effects related to Chantix.
Meanwhile, the US Food and Drug Administration (FDA) recently approved the Medication Guide on Chantix and issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and both attempted and completed suicide. Many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning—the agency’s highest safety alert.
Despite this, health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking despite the drug’s association to suicidal thoughts and behavior. And, while the new smoking cessation guidelines, published by the US Public Health Service, do note the Chantix links with suicide and other psychiatric side effects, the Pfizer drug is promoted as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also because their lead author, Dr. Michael Fiore, has ties to Pfizer.
As FDA’s review of the problems with Chantix has continued, the FDA states it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” It was because of this that the FDA requested that Pfizer elevate the prominence of this safety information. In the US, 34 Chantix users have reportedly committed suicide. According to an FDA November 20 Early Communication, the agency said its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
A few weeks ago, ABC News, in conjunction with The Washington Times, aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with PTSD - had not been told that the drug was linked to depression, suicide and psychotic behavior. According to the ABC News report, hundreds of Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month to participate in a Chantix behavioral study. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA’s notice didn’t specifically mention suicide.
Following the outcry that resulted from the ABC report, VA Secretary James Peake told a Washington Times reporter that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA.
A review by the VA Office of Inspector General found that researchers in the study "did not ensure that patients involved in the smoking cessation study were notified of the risk of suicidal thoughts or behavior in a timely manner."
The ABC News report quickly caught the attention of Congress, and yesterday, Peake appeared before the House Committee on Veterans' Affairs to explain the VA's handling of the Chantix trial. Peake has said he "wished" the VA had not taken so long to warn veterans being used in the Chantix test. Peake said his department will now review all drugs prescribed by the VA to veterans with PTSD. Part of that review will be to examine the risks of medications on PTSD vets and to review proper notification procedures.
Committee chair Bob Filner (D-Ca) asked Peake repeatedly why the Chantix study hasn't been ceased. But Peake said that until the VA's internal review on the handling of Chantix is completed, there is no reason to take further action.
In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
Chantix again made headlines in May, when the Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The study specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers.
According to The Washington Times report, Principi contacted officials at the VA after the Institute released its report. Pfizer claims that all Principi did was pass along requests via e-mail asking whether an internal VA study that examined 27 veterans hospitalized for psychotic episodes while taking Chantix would be made public. A company official told the Times that it doesn't consider that to be lobbying - even though Principi was employed as Pfizer's chief lobbyist.
But e-mails reviewed by The Washington Times also reveal that Mr. Principi forwarded inquiries from Pfizer about Chantix's status on the VA's list of prescribed drugs, at one point stating, "I really hate to be a pain, but I keep getting asked these questions."
This isn't the first time that the VA's dealings concerning Chantix have raised concerns. Last month, it was learned that the agency allowed veterans with Post Traumatic Stress Disorder (PTSD) to be enrolled in a Chantix trial, but waited months after the FDA issued its last suicide warning to notify the trial participants - along with thousands of other veterans prescribed Chantix through the VA - about those dangers.
In fact, it wasn't until a joint ABC News/Washington Times investigation questioned the Chantix clinical trial that the VA sent out a Chantix warning that specifically mentioned suicide.
A few weeks ago, ABC News aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with post traumatic stress disorder (PTSD) - had not been told that the drug was linked to depression, suicide and psychotic behavior. According to the ABC News report, hundreds of Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month to participate in a Chantix behavioral study. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA’s notice didn’t specifically mention suicide.
Following the outcry that resulted from the ABC report, VA Secretary James Peake told a Washington Times reporter that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA. Peake also said he has asked VA doctors to review “the communications process” involving all VA studies using veterans who are suffering from PTSD. Some 400,000 veterans are being treated for PTSD by the VA.
But it now appears that doctors at the VA were concerned about Chantix side effect reports months before the FDA issued its November Chantix Early Communication. According to the Washington Times, doctors at the VA were getting reports of disturbing behavior among some Chantix users in early 2007. By November, the VA had data that indicate that nearly one out of every 1,000 veterans taking Chantix had been hospitalized for severe psychosis, a rate noticeably higher than for veterans trying to stop smoking with alternative treatments like nicotine replacement, the documents show.
Even with those disturbing numbers, the VA was prescribing Chantix to more and more veterans - and it was continuing to enroll vets with PTSD in the Chantix behavioral study. The VA has since acknowledge that the rate serious side effects among PTSD patients in that trial was about one out of every two veterans.
Faced with mounting reports of psychiatric side effects, the VA began an investigation in November 2007, which took the agency 4 months to complete. That review found that among 27 patients taking Chantix who were admitted to VA hospitals for psychiatric problems since the drug was approved for the market in 2006, 11 had attempted suicide, one attempted homicide, nine had suicidal thoughts, and six were suffering from hallucinations. The rate of such hospitalizations for Chantix users - about 9.8 for every 10,000 patients - was much higher than it was among veterans using other smoking cessation methods. By the time the VA report was completed in March 2008, the FDA had already issued several Chantix warnings, and the drug's labeling was updated to make warnings on suicide and other psychiatric side effects more prominent.
But the VA did not make its Chantix study public, and officials who conducted it never recommended that veterans taking the drug be issued a warning. It wasn't until May that the agency sent out a letter telling veterans that they should be careful operating heavy machinery if they are taking Chantix. Finally, on June 18 - after ABC News aired its report - the VA finally sent out letters to all veterans taking the drug to specifically warn them that suicidal tendencies were a possible side effect.
Tomorrow, a Congressional committee will be looking at the VA's handling of the Chantix debacle. Those scheduled to testify at the hearing include VA Secretary James B. Peake and Dr. John D. Daigh, assistant inspector general. Lawmakers will be wanting an explanation for the VA's long delay in warning veterans about the dangers associated with Chantix.
In April, Health Canada issued an alert warning that Chantix has been linked to 107 adverse reactions in Canada. According to the ageny nearly half of those reports involved psychiatric behavior. In its latest alert, Health Canada has said that in the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported in patients taking the drug.
Health Canada also issued the following guidelines:
- People taking Chantix should tell their doctor if they experienced depression or other mental health problems before taking Chantix, as these symptoms may worsen while taking the drug.
- Patients should stop taking Chantix and tell their doctor right away if they, their family or caregiver notice any of these symptoms, if they experience these symptoms in a way that is not typical for them or if they have thoughts of self-harm or of harming others.
- Chantix has not been studied in people with mental health problems, and therefore a doctor should monitor such patients closely for new or worsened emotional or behavioral problems while on the medication.
In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
According to the ABC News report, hundreds of Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month to participate in a Chantix behavioral study. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn't until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA's notice didn't specifically mention suicide.
Following airing of the ABC News Report, VA Secretary James Peake told a Washington Times reporter that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA. Peake also said he has asked VA doctors to review "the communications process" involving all VA studies using veterans who are suffering from PTSD. Some 400,000 veterans are being treated for PTSD.
Still, the VA will allow the Chantix study using PTSD veterans to continue, however no more participants will be enrolled. Peake said he would not have any problems halting the Chantix study if needed, but insisted that there is no evidence that such a more is necessary.
In the US, 34 Chantix users have reportedly committed suicide. In November 2007, the Food & Drug Administration (FDA) issued an "Early Communication" that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
Last month, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. The report caused the Federal Aviation Administration to ban the use of Chantix by pilots and air traffic controllers.
Now, a joint investigation conducted by ABC News and the "Washington Times" is raising questions about the ethics of some Chantix clinical trials. James Elliott, a 30-year-old ex-Army sniper diagnosed with PTSD told ABC News that he agreed to participate in a Chantix trial for $30.00 per month. Months after he began taking the drug, Elliott suffered a mental breakdown, experiencing a relapse of Iraq combat nightmares he blames on Chantix.
One night this past February, he "snapped" and left home with a loaded gun. His fianc e called police, concerned because he was acting as though he was still in combat. Police had no choice but to subdue Elliott with a taser and arrest him.
Three weeks later, the Veterans Administration finally advised the participants in the Chantix study that the drug may cause serious side effects, including "anxiety, nervousness, tension, depression, thoughts of suicide, and attempted and completed suicide." By the time that notice went out on February 29, 2008, the FDA had already issued three separate Chantix suicide warnings. But officials at the Veterans Administration told ABC News that those warnings "didn't justify an emergency warning at that level."
The same official also told ABC News that the Veterans Administration sees no reason to discontinue the Chantix study. As it stand right now, about 140 veterans diagnosed with PTSD continue to receive Chantix as part of a smoking cessation study.
Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Since its approval, over 6 million Chantix prescriptions have been written.
In the US, 34 Chantix users have reportedly committed suicide. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency's highest safety alert.
Last month, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. The report caused the Federal Aviation Administration to ban the use of Chantix by pilots and air traffic controllers.
Dr. Spangler is one person who is not surprised that questions have arisen about the safety of Chantix. According to report on ABC News, last year, he raised concerns about heart and vision effects in people who took the drug for at least one year. Spangler told ABC that a safety study by researchers employed by Pfizer and published in a relatively obscure medical journal looked at far too few subjects — a total of only 251 taking the drug — to determine whether or not the drug is safe when used over that duration. Yet, the researchers concluded that Chantix could be safely administered for up to one year.
Dr. Spangler also did his own analysis of the Chantix study, and told ABC News that the authors failed to mention that study subjects who took the drug were 2.5 times as likely to experience a serious adverse event. Dr. Spangler said the small size of the study made it impossible to determine if the adverse events were the results of chance, or were caused by Chantix.
It is Dr. Spangler's contention that a bigger study must be conducted to determine the safety of Chantix. Until it is done, doctors who prescribed the drug must consider the possibility that an increased risk exists. To date, the FDA has not asked Pfizer to conduct such a long-term study.