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Viagra, Cialis Amnesia Reports Prompt Labeling Change

Aug 25, 2008 | Parker Waichman LLP

The labeling for Viagra and Cialis will now include information about Transient Global Amnesia (TGA), a side-effect that may occasionally accompany use of the erectile dysfunction (ED) drugs.  A third ED drug, Levitra, had information about the temporary form of memory loss added to its label in June.

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.


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