Viagra, Levitra, Cialis linked to hearing loss
The US Food and Drug Administration has decided to put more prominent warnings of potential hearing loss on impotence drugs Viagra, Cialis and Levitra.
An FDA statement said the goal was “to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.”
Revatio, used to treat pulmonary hypertension, also will get the same labelling changes, the FDA said.
The warnings followed what the administration called “a very small number” of patients reporting hearing loss and at times ringing in the ears and dizziness.
“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, MD, FDA deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
Anti-impotence drugs linked to hearing loss
The U.S. Food and Drug Administration has approved labelling changes for three kinds of erectile dysfunction drugs to display more prominently the potential risk of sudden hearing loss.
The FDA on Thursday asked manufacturers of Viagra, Cialis and Levitra to revise product labelling after a very small number of patients taking the drugs reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
It’s not clear if the drugs actually trigger hearing loss, but the agency decided to act after counting 29 reports of hearing problems since 1996 among users.
Dr. Robert Boucher, an agency ear, nose and throat specialist, said in reviewing the reports he noticed that the hearing loss occurred within hours to two days of taking one of the drugs.
“We don’t know enough to say that it’s ironclad caused by the drugs, but we see enough to say we can’t ignore it either,” he said.
The reports involved hearing loss in one ear, which in a third of cases was temporary.
The FDA has urged patients who experience any hearing problems, loss or ringing in the ears to promptly call their doctors and stop taking the impotence drugs.
Because some level of hearing loss is usually associated with the aging process, patients taking these drugs (phosphodiesterase type 5 inhibitors) may not think to talk to their doctor about it, said Dr. Janet Woodcock, the FDA’s chief medical officer.