The U.S. Food and Drug Administration said Thursday it's approved new erectile dysfunction drug labels to more prominently display the potential risk of sudden hearing loss.
The labeling change - first reported by CNBC - applies to Pfizer Inc.'s (PFE) Viagra, Eli Lilly & Co.'s (LLY) Cialis, Levitra marketed by GlaxoSmithKline PLC (GSK), Schering-Plough Corp. (SGP) and Bayer AG (BAY). The agency said the change will also apply to Pfizer's Revatio, a drug with the same active ingredient as Viagra that's used to treat pulmonary arterial hypertension.
The FDA said it found a total of 29 reports of sudden hearing loss among patients taking the erectile dysfunction drugs. The agency said the search of its adverse-events database was prompted by a case report in medical literature of a patient with sudden hearing loss who was taking Viagra. Such adverse-event reports, which are filed to the FDA by drug companies, doctors and patients, does not mean a particular drug has caused a problem.
The FDA said hearing loss was also reported in a few patients in clinical trials of these drugs. The FDA said in most cases the sudden hearing loss occurred in one ear.
All of the drugs fall into a category of drugs known as PDE5 inhibitors.
"Though no causal relationship has been demonstrated, FDA believed that the strong temporal relationship between the use of PDE5 inhibitors and sudden hearing loss in these cases warranted revisions to the product labeling for the drug class," the FDA said in a statement posted on its Web site.
The agency noted that hearing loss is commonly reported in an aging population, especially in patients with risk factors for erectile dysfunction. "However, sudden hearing loss is an uncommon event at any age," the agency said.
1 comment:
It is now widely accepted that the leading causes of impotence are poor circulation, diabetes and other illnesses.
Perhaps it may be better to focus on correcting the medical condition instead of taking impotence drugs.
Besides, herbs, such as tongkat ali, widely found here in Malaysia where I live, and others, can be taken instead of pharmaceutical drugs.
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