FDA Orders Label Changes For Erectile Dysfunction Drugs
As if men with erectile dysfunction didn't already have enough to think about, now comes the news that a small number of men who've taken Viagra or other erectile dysfunction drugs experienced hearing loss after taking the drug. As a result, the U.S. Food and Drug Administration in October 2007 approved new warning labels for Viagra, Cialis and Levitra, which will now include the possible risk of sudden hearing loss among other potential side effects of the drugs.
Twenty-Nine Reports of Hearing Loss Since 1996
The FDA was prompted to take action after reviewing case reports and a database of "adverse events" that followed the use of erectile dysfunction medication like Viagra. The review found that since 1996, there were twenty-nine reports of sudden hearing loss in men who were taking Viagra or another erectile dysfunction drug. In the majority of cases, the hearing loss occurred in one ear only.
The FDA's announcement also says the hearing loss was either partial or complete and was temporary in 1/3 of the cases. In the other 2/3, the hearing loss was still ongoing at the time of the FDA's report or the final outcome wasn't known.
Even before the FDA took action, the warning label for Viagra mentioned hearing loss as a possible side effect since a few cases of hearing loss were reported during early trials of the erectile dysfunction drug.
In addition to new labels for all three erectile dysfunction drugs, the warning will also apply to the pulmonary hypertension drug Revatio, which has the same active ingredient as Viagra.
No Causal Relationship Established
In explaining its actions, the FDA was clear in stating that there was no way to determine whether Viagra or the other erectile dysfunction drugs actually caused the hearing loss, or whether the hearing loss was due to some unrelated factor.
In fact, both hearing loss and erectile dysfunction are more common among older men, so it is possible that the connection between the two is accidental. Hearing loss has also been linked to both heart disease and diabetes, each of which has been identified as a cause of erectile dysfunction.
Hearing Loss Affected Miniscule Percentage of Viagra Users
In terms of the total number of men who have taken Viagra and other erectile dysfunction drugs over the years, the fact that there were twenty-nine reports of hearing loss may not be statistically significant. The risk of suffering hearing loss from using Viagra is clearly far below the risk of experiencing some of the more common and milder side effects of Viagra, which include headache, flushing and upset stomach.
Still, the FDA felt that the potential risk should not be ignored. In addition to the modified warning labels, the FDA has recommended that anyone who does experience ringing in the ears or hearing loss after taking Viagra or another erectile dysfunction drug should stop taking the drug and promptly contact their physician.
Viagra And Hearing Loss Sources:
FDA News Release: Viagra, Cialis, Levitra Labeling Changes Announced
FDA's Questions and Answers About Labeling Changes
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