TGA is a sudden, temporary episode of memory loss that can’t be attributed to a more common neurological condition, such as epilepsy, transient ischemic attack, stroke or head injury. During an episode of transient global amnesia, recall of recent events simply vanishes, so a victim is unable to remember where they are or how they got there. They may also draw a blank when asked to remember things that happened a day, a month or even a year ago.
Victims of TGA do remember who they are, and they will recognize family members and others they have known for a long time. When an episode of TGA is over, a victim will remember nothing that happened while their memory was impaired, and might not recall the hours beforehand.
The new information on TGA for Viagra and Cialis does not amount to a safety warning, but will be added to the "Postmarketing" section of the drugs' labels. Such label changes usually mean that multiple users have reported health problems after taking a drug, but the reports don't necessarily mean that the drug caused the problem, according to the Food & Drug Administration (FDA).
Despite a lack of direct evidence linking the ED drugs to TGA, this isn't the first time they have been implicated in the condition. A 2005 article in the International Journal of Impotence Research described the case of a 46-year-old man who was brought to the emergency room because he had couldn't remember any events since waking up in the morning or the night before, taking Cialis. His memory gradually improved, and tests for cardiovascular and brain problems - potential causes of TGA - came back normal. According to the authors of that article, there had been 35 reports of amnesia in Viagra users between 1998 and 2001.
Other side effects have resulted in other labeling changes for Levitra, Cialis and Viagra. In 2005, warnings about vision loss were added to their labels. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
In 2006, a second warning was added to the label of Levitra, Cialis and Viagra regarding sudden hearing loss related to the medications. The FDA said the warning was prompted by more two dozen instances of sudden hearing loss linked to the drugs. In about a third of those reports, the hearing loss was permanent.
TGA is a sudden, temporary episode of memory loss that can't be attributed to a more common neurological condition, such as epilepsy, transient ischemic attack, stroke or head injury. During an episode of transient global amnesia, recall of recent events simply vanishes, so a victim is unable to remember where they are or how they got there. They may also draw a blank when asked to remember things that happened a day, a month or even a year ago.
Victims of TGA do remember who they are, and they will recognize family members and others they have known for a long time. When an episode of TGA is over, a victim will remember nothing that happened while their memory was impaired, and might not recall the hours beforehand.
According to the FDA, the Levitra label got the transient global amnesia note "because of a limited number of post-marketing reports of men who experienced TGA" around the time they took Levitra. The FDA is stressing that no direct link has been found between TGA and Levitra. The agency has also said that the reported instances of TGA in men taking Levitra may have been spurred by something else, even by sex.
This is the third labeling change for Levitra since 2005. At that time, warnings about vision loss were added to the label of Levitra, as well as Viagra and Cialis - two other ED drugs. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
In 2006, a second warning was added to the label of Levitra, Cialis and Viagra regarding sudden hearing loss related to the medications. The FDA said the warning was prompted by more two dozen instances of sudden hearing loss linked to the drugs. In about a third of those reports, the hearing loss was permanent.
Following the publication of a report in the Journal of Laryngology and Otology, the FDA conducted a search of its adverse event reporting system for cases of hearing loss in patients taking Viagra, Levitra and Cialis. Twenty-nine postmarketing reports of sudden hearing loss defined as new hearing loss occurring over a period of 3 days or less following the last dose, both with and without tinnitus and dizziness, were identified. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. In the majority of the Viagra, Levitra and Cialis users who experienced this problem, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in two thirds of the cases the hearing loss was permanent.
The FDA is advising physicians who prescribe Viagra, Levitra or Cialis for erectile dysfunction to tell their patients to immediately stop taking the drug if they experience any sudden decrease or loss of hearing and seek prompt medical attention. The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing. But the new labeling on Viagra, Levitra and Cialis will include much more information. The new warning on sudden hearing loss will be included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra, Levitra and Cialis. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”, whereas t
he previous label simply stated “deafness” as a possible side effect.
This is the second time that the Viagra, Levitra and Cialis labels have been changed to warn of a serious side effect. In 2005, warnings about vision loss associated with the drugs were added to their labels. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
Viagra, Levitra and Cialis are PDE5 Inhibitors that relax muscles and increase blood flow to certain parts of the body. Viagra, the most well-known of the PDE5 Inhibitors on the market, was approved in 1998 to treat male erectile dysfunction. Another PDE5 Inhibitor, Revatio, is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women. In announcing the changes to the Viagra, Levitra and Cialis labels, the FDA also said that it was working with the maker of Revatio to update that drug’s labeling to also include warnings on sudden hearing loss.
The FDA’s decisions to change the labeling on Viagra, Levitra and Cialis comes seven months after an article in the April issue of the Journal of Laryngology & Otology published a case report on a 44-year-old man who experienced this sudden hearing loss after taking Viagra for 15 days. Since then, other such cases have been reported. So far, the FDA says it knows of sudden hearing loss occurring in 29 patients taking PDE5 Inhibitors. Many men who use Viagra, Levitra and Cialis are elderly, and gradual hearing loss is not uncommon in this group of patients. However, sudden hearing loss is highly unusual. As a result, the FDA asked the manufacturers of Viagra, Levitra and Cialis to update the drugs’ labeling to include warnings about this serious side effect.
The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing. But the new labeling on Viagra, Levitra and Cialis will include much more information. The new warning on sudden hearing loss will be included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra, Levitra and Cialis. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”, whereas the previous label simply stated “deafness” as a possible side effect.
In the majority of the Viagra, Levitra and Cialis users who experienced this problem, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in two thirds of the cases the hearing loss was permanent.
This is the second time that the Viagra, Levitra and Cialis labels were modified due to a serious side effect. In 2005, the labels were changed to include warnings about vision loss associated with the drugs. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
Viagra, Levitra and Cialis are PDE5 Inhibitors that relax muscles and increase blood flow to certain parts of the body. Viagra, the most well-known of the PDE5 Inhibitors on the market, was approved in 1998 to treat male erectile dysfunction. Another PDE5 Inhibitor, Revatio, is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.
In the 10 years since Viagra was approved, the FDA has received reports of sudden hearing loss in 29 patients taking PDE5 Inhibitors. In most of the 29 cases, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary.
Many men who use Viagra, Levitra and Cialis are elderly, and gradual hearing loss is not uncommon in this group of patients. However, sudden hearing loss is highly unusual. As a result, the FDA asked the manufacturers of Viagra, Levitra and Cialis to update the drugs’ labeling to include warnings on sudden hearing loss.
The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing. But the new labeling on Viagra, Levitra and Cialis will include much more information. The warning on sudden hearing loss will be included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of PDE5 Inhibitors. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”, whereas the previous label simply stated “deafness” as a possible side effect.
This is not the first time that the Viagra, Levitra and Cialis labels were modified due to a serious side effect. In 2005, the labels were changed to include warnings about vision loss associated with the drugs. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.
The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.
A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored. NAION is one of the most common causes of abrupt vision loss in older individuals.
People with diabetes and heart disease are specifically at risk for developing NAION. Incidentally, these two risk factors are also two of the leading causes of impotence.
In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.
At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.
In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.
The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.
Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.
Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra. Other visual problems were reported by an additional 50 people.
Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.
Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs. The only acceptable solution, he says, is for a black-box warning to be issued.
All of this began on May 27, when the FDA disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra).
To be sure, NAION is a very rare condition and the FDA was quick to point out that a definite link between the drugs and the condition has not been established. Yet, the possibility that such a serious side-effect exists was enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION.
On July 8, the FDA approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION .
The FDA advised patients to stop taking these medicines, and call a doctor or healthcare provider immediately if they experience sudden or decreased vision loss in one or both eyes.
Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.
The FDA stated that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.
The new labeling information is available along with additional information for healthcare providers and consumers online at:
Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)
Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)
Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)
The Advisory from Health Canada follows:
“Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.
The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible.
Risk factors for NAION include:
• age greater than 50 years
• heart disease
• high blood pressure
• high cholesterol
• diabetes
• smoking
• certain pre-existing eye problems
An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.
Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer AG/GlaxoSmithKline (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.
While Health Canada's assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.”
The FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes.
Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.
The FDA states that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.
The new labeling information is available along with additional information for healthcare providers and consumers online at:
Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)
Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)
Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)
For the past seven years, the jubilation surrounding the availability of drugs like Viagra, Cialis, and Levitra has been remarkable. No other drugs since oral contraceptives have had such a dramatic impact on sexual practices and expectations. As with every other powerful prescription drug, however, the day of reckoning regarding potentially dangerous side-effects was always lurking in the shadows. That day has now arrived.
The FDA has disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra). To be sure, NAION is a very rare condition and the FDA was quick to point out that a definite link between the drugs and the condition has not been established. Yet, the possibility that such a serious side-effect exists is enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION. Pfizer (Viagra) is considering a label change while Eli Lilly (Cialis) has already added a reference to the reports of NAION. GlaxoSmithKline (Levitra) has not made any public Statement on the matter. .
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