The patches are meant to slowly deliver medication transdermally, or through the skin. But, some transdermal patches contain metal in the layer of the patch—generally the backing—that is not in contact with the skin and is not always visible. The labeling for most of the medicated patches that contain metal in the backing provides a warning to patients about the risk of burns if the patch is not removed before an MRI scan; however, not all transdermal patches that contain metal contain these warning labels, said the FDA.
The FDA is currently in the process of reviewing the labeling and composition of all such medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan.
Until the agency’s review is complete, it recommends that healthcare professionals referring patients for an MRI scan identify those patients who are wearing a patch before the scan conducted and to advise those patients about how to remove and dispose of the patch before undergoing the MRI scan, and how to replace the patch following the scan.
The FDA suggests that MRI facilities follow published safe practice recommendations concerning patients who are wearing patches (Kanal, et. al, “ACR Guidance Document for Safe MR Practices: 2007,” AJR 2007; 188:1–27 and Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009) and, until the safety issue is resolved, recommends the following for patients who use any type of medicated patch, including nicotine patches:
Advise the referring physician that you are using a patch and for what use the patch has been prescribed, such as for pain, smoking cessation, or hormone therapy, for example.
Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.
Tell the MRI facility—at the time you make your appointment and when you provide answers to health history questions—that you are using a patch.
The FDA is also urging health care professionals and patients to report possible cases of skin burns while wearing patches during an MRI to the FDA through its MedWatch program. MedWatch can be reached by telephone toll-free at 1-800-FDA-1088 or via the Internet at http://www.fda.gov/medwatch/index.html.
Risperdal is one of class of drugs called atypical antipsychotics. Other atypical antipsychotics include Eli Lilly's Zyprexa, and AstraZeneca's Seroquel. These drugs have long been linked to an increased risk of weight gain and diabetes. According to Bloomberg News, in 2003, the Food & Drug Administration (FDA) required the makers of antipsychotics to warn about this risk.
The State of West Virginia had brought suit against Johnson & Johnson and its Janssen unit over claims made in the 2003 letter to doctors, Bloomberg News said. The FDA had already cited the same letter for being misleading. West Virginia Circuit Court Judge Martin Gaughan agreed, writing that the letter was "deliberately constructed to circumvent the FDA's mandated warning for an increased risk of diabetes, and deliberately constructed to mislead health-care professionals."
According to Bloomberg News, the judge fined Johnson & Johnson $1.95 million for the letter and an additional $2 million for Risperdal sales calls made in West Virginia from November 2003 to July 2004.
The makers of antipsychotics have faced increasing scrutiny over the way these drugs are marketed. Hundreds of lawsuits have been filed by individuals who claim the drug's diabetes risks were hidden. Meanwhile, federal and state authorities have, like West Virginia, filed lawsuits over the drugs' illegal promotion.
Earlier this year, Eli Lilly agreed to pay $1.4 billion in fines to settle federal charges over its promotion of Zyprexa. Documents unsealed in Seroquel litigation indicate that, among other things, AstraZeneca directed sales reps to downplay the drug's diabetes risks.
In West Virginia, Judge Gaughan also assessed Johnson & Johnson and Janssen a $525,000 fine for distributing a brochure that contained misleading information about the Duragesic patch. According to a report on WOWKTV.com, the FDA had also warned the companies that the brochure was misleading.
In his order, Judge Gaughan wrote that "The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however . . . the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale.”
Fentanyl patches, like the Duragesic Patch, have long been linked to accidental overdoses. In December 2007, FDA issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.
According to an article on USNews.com, the FDA sent letters to 16 pharmaceutical companies that manufacture the two dozen narcotic painkillers that will be subject to the new review. Drugs like the Duragesic fentanyl patch and Oxycontin are prescribed to treat chronic pain from cancer and other ailments. According to the FDA, approximately 21 million prescriptions for 3.7 million patients were issued in 2007 for these medications. A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.
In a press release, the FDA said that drug manufacturers have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations, and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA said it believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access.
The FDA has scheduled a meeting with drug makers for March 3. After that meeting, the agency will work on putting new regulations in place for the painkillers. USNews.com said the FDA expects the process to last for several months. The new regulations could encompass additional warning labels, physician instructional materials, and stricter prescription indications, the report said.
Yesterday, we reported that the FDA and CDC had announced that they would be providing grants for research aimed at finding strategies to combat accidental painkiller overdoses. According to the agencies, accidental overdose deaths from narcotics or hallucinogens in the 15-64 years age range rose 5,921 in 1999 to 10,829 in 2005, an 83 percent increase. Unintentional overdoses not resulting in fatality saw a 44 percent increase from 376,611 to 542,372 accidents in the same time frame and within the same age group. Opioids painkillers were the prevailing factor in all the incidences.
According to the FDA, overdoses can occur if patients do not know how to take the drugs or if doctors drugs in a way that is not appropriate. Other overdose deaths occur when legitimate prescriptions get into the hands of people other than the intended patient.
The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.
Health Canada
Health Canada also said that patients using Fentanyl Transdermal Systems should be advised to seek emergency medical help immediately if they:
- have trouble breathing, or have slow or shallow breathing
- have a slow heartbeat
- have severe sleepiness
- have cold, clammy skin
- feel faint, dizzy, confused, or cannot think, walk, or talk normally
- have a seizure
- have hallucinations
Fentanyl patches have long been linked to accidental overdoses. Just last week, we reported that Ortho-McNeil-Janssen had recalled one lot of Duragesic 50 mcg/hr patches because of a defect that could cause fentanyl overdose. The recall also included one lot of Sandoz Inc. 50 mcg/hr patches.
Last February, the company also recalled 32 million Duragesic Pain Patches for a similar defect. At the time, it was estimated that about two out of every million patches could be defective.
In December 2007, the U.S. Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.
The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.
The most recent Johnson & Johnson patch recall involves one lot of Duragesic 50 mcg/hr patches under the lot number 0817239 sold by PriCara. The recall also includes one lot Sandoz Inc. 50 mcg/hr patches under the lot number 0816851.
PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson. ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. A press release issued by PriCara said that other strengths of the patches, including 12.5, 25, 75 and 100 mcg/hr, are not affected.
In the press release, the company said it had identified a condition in manufacturing equipment that resulted in a cut-system defect in a small number of affected patches in the lots being recalled. The defect could result in a release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal, the release said.
PriCara is advising that anyone who has any of the recalled fentanyl patches should check the box or foil pouch to see if they have patches from the recalled lots. Cut patches should not be handled directly. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only. Soap, alcohol, lotions, oils or other products to remove the medicine gel should not be used because they may increase the medicine's ability to go through the skin.
Patches with cut edges should be disposed of by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief, PriCara said.
Last February, Johnson & Johnson recalled another 32 million Duragesic Pain Patches for a similar defect. At the time, the company estimated that about two out of every million patches could be defective.
In December 2007, the FDA issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.
The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with products like the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.
Fentanyl-containing Duragesic Pain Patches and similar products are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.
Over the past several years, problems with Duragesic patches have resulted in several recalls. Last February, about 32 million Duragesic Pain Patches were recalled because of concerns that they could be defective. According to the recall notice, there was a chance that some 25-microgram-per-hour patches might have had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. It was estimated that the defect could have affected 2 out of every one million patches.
In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.
The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.
According to the Associated Press, 38-year-old Jerry DiCosolo died in 2004 while using a Duragesic Pain Patch to treat pain she suffered as a result of a neurological problem. The lawsuit filed by DiCosolo's family claimed that Janssen and ALZA knew about problems with the Duragesic patch that allowed it to leak fentanyl in doses large enough to kill patients.
According to Bloomberg.com, this is the fourth Duragesic case that Johnson & Johnson has lost in the past two years. Last month, a Florida jury awarded more than $13 million to the family of a 34-year-old woman who died after using a Duragesic patch in 2002. Bloomberg.com also reports that in July 2006, a state court jury in Houston ordered Janssen and ALZA in July to pay $772,500 to the family of a Texas woman who died after her patch leaked.
Johnson & Johnson also agreed to pay the family of a Florida man $2.5 million in 2007 to resolve claims that he died as a result of a defective Duragesic patch, Bloomberg.com said. That settlement was reached after a jury had awarded the victims family $5.5 million at trial a month early.
The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.
Today's Duragesic Patch recall includes all 25-microgram-per-hour patches that are sold in the U.S. by J&J's PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp. All of the recalled Duragesic patches have expiration dates on or before December 2009. The defective Duragesic patches have a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.
The Duragesic Pain Patch has been a problematic device ever since it first came on the market. In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch "misuse" and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.
The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.
Jerry Parker, Managing Partner at Parker Waichman Alonso, LLP, said today's recall was not surprising considering Johnson & Johnson's track record with medicated patches. "Both the Duragesic and the Ortho Evra Birth Control Patch have caused serious injuries to users because of defects that allow the patches to deliver far more medication than is safe," Parker said. "This recall just points to the continuing problems Johnson & Johnson is having with its patch technology." Parker's law firm is currently representing plaintiffs who were injured by Johnson & Johnson's Duragesic and Ortho Evra patches.
The Johnson & Johnson Ortho Evra Birth Control patch was the subject of an FDA warning only last month after a study linked Ortho Evra to the development of a potentially dangerous type of blood clot. That warning was the FDA's second Ortho Evra blood clot warning issued since it was introduced to the market in 2002. In 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism - as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.
The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose. The Duragesic and similar patches use so-called “transdermal” technology developed by California-based Alza Corporation.
In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. That advisory emphasized the appropriate and safe use of fentanyl painkilling patches. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches.
Since the original 2005 health alert, the FDA has received further reports of deaths related to Duragesic and generic fentanyl pain patches, although the agency declined to reveal how many additional reports it has been received. As was the case in 2005, the FDA says that many of the deaths are related to fentanyl patch misuse. The FDA found cases where doctors wrongly prescribed it for headaches or post-surgical pain. But the FDA says patients also are accidentally overdosing by using the patches wrong, such as putting on more than prescribed, replacing them too frequently or getting them too hot.
Today, the FDA announced that it had ordered fentanyl patch makers to create special "medication guides" for patients that spell out the dangers of overdoses and improper use in easy-to-understand language. Among the many warnings to be contained in the new medication guides is the caution that fentanyl patches can cause trouble breathing, which can be fatal. Patients will be instructed to get emergency help if they have trouble breathing or extreme drowsiness with slowed breathing; feel faint, dizzy, confused; or have other unusual symptoms. These symptoms can be signs that a patient was prescribed too high a dose or took too much. The FDA is also warning that fentanyl patches are only for round-the-clock pain that is moderate to severe and expected to last for weeks. They are not for sudden, occasional or mild pain or pain after surgery.
“The settlement indicates that Johnson & Johnson realizes the seriousness of these cases and that they have to pay serious money to resolve them,” Alex MacDonald, a lawyer based in Boston, told Bloomberg.com. MacDonald has four cases involving Duragesic overdoses set to go to trial next year, while as many as 300 to 400 more similar suits have been filed, according to Bloomberg.
Johnson & Johnson may now have to consider an all-inclusive settlement for the many pending wrongful death suits, as it has lost both cases that have gone to trial. A jury awarded $772,500 in damages in a suit involving a Texas woman overdosed when her Duragesic patch leaked fentanyl onto her skin instead of administering it in a controlled dose. That case is still under appeal, Bloomberg.com reported.
In July 2005, the federal Food and Drug Administration (FDA) issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. Mylan Pharmaceuticals, a manufacturer based in Morgantown, West Virginia, has sold a fentanyl transdermal patch since it received FDA approval in January 2005. The results of the FDA probe are still pending. The agency is “continuing to investigate the safety of these patches to assure they remain safe and effective,'' FDA spokeswoman Kimberley Rawlings told Bloomberg.
The Duragesic painkilling patch, which disperses fentanyl directly through the skin, uses so-called “transdermal” technology developed by California-based Alza Corporation. Janssen Pharmaceutica, the defendant named in the recently settled Florida suit, marketed the Duragesic patch in the United States, but does not currently have the product listed on its Web site. Both Alza and Janssen are part of the Johnson & Johnson “family of companies.”
The jury in the Florida case found that officials employed by Johnson & Johnson were aware of the defects in the Duragesic product, but neglected to inform doctors and consumers about the potential risks. Jurors awarded $5.5 million to the family of Adam Hendelson in June, and Johnson & Johnson agreed to drop its appeal of the case as part of the settlement.
In 2004, the (FDA) recalled all 75 mch/h Duragesic patches, the line of the product that dispenses 75 micrograms of medicine per hour. That recall has since been expanded to include four more versions of the Duragesic patch. Recalled patches could potentially leak fentanyl if their edges are not properly sealed, leading to an excess of the prescription painkiller, a medicine stronger than morphine, and being absorbed into the body.
Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused, according to the FDA’s Web site.