The FDA has just approved changes to product labeling for popular “lifestyle” drugs Viagra, Cialis, and Levitra. These drugs are meant to treat erectile dysfunction or ED, and my calling them “lifestyle” drugs will trigger the ire of pharma companies, but let’s face it, these types of drugs don’t become blockbuster for no reason.
If you didn’t know, Viagra was born of research on a compound originally intended to treat heart disease. Who knew that the interesting side effect of the compound would create such a media sensation? (not to mention all the lame jokes and commercials accompanying these medications)
The FDA began investigating the potential link between Viagra and similar drugs with hearing loss after reading a case report published in April 2007 in the Journal of Laryngology & Otology. The agency found 29 post-marketing reports of sudden hearing loss in one ear for patients taking Viagra and similar compounds. Now, the FDA wants the drug makers to warn consumers taking ED drugs about the risk of sudden hearing loss after “a very small number of patients” reported sudden hearing loss, sometimes with ringing in the ears and dizziness. Patients who experience sudden hearing loss are advised to stop taking the drug immediately and get medical help.
Given the number of prescriptions that have been dispensed for Viagra and family, 29 reports of sudden hearing loss really isn’t a “big” number. However, let’s take this in the context of the current media attention on children’s cough medication calling to be banned because of less than 60 total deaths over the span of more than 35 years (1969-2006). Even if infant deaths due to cough mixture were attributed to inappropriate dosing, 29 drug-related adverse events of anything these days may be too many to be ignored.