Think again if you're entertaining the thought of Viagra
WASHINGTON -- U.S. regulators added new warnings Thursday about the potential risk of sudden hearing loss to best-selling impotence drugs viagra cialis online pharmacy pharmacy, Cialis, and Levitra.
The U.S. Food and Drug Administration said a published report of a man taking Pfizer Inc's Viagra, who suffered from sudden hearing loss, prompted it to explore a possible association.
A further review of the FDA's side-effect data found 29 cases of sudden hearing loss with a relationship to the three drugs taken by millions of men.
In one-third of the cases the hearing loss was temporary, the agency said, the remaining cases were described as continuing at the time of the report or the outcome was not described.
Eli Lilly sells Cialis and GlaxoSmithKline Plc sells Levitra. Pfizer's Revatio, a version of Viagra used for a lung condition, will also carry a new warning.
Erectile dysfunction drugs are a huge business, with Pfizer reporting Viagra sales of $450 million in its most recent quarter. The drug makers are all cooperating with the FDA and defended the safety of their drugs.
The new label warnings follow a 2005 label change noting cases of sudden vision loss in some patients.
Reports of serious side effects to the FDA's safety database are widely viewed as representing only a fraction of actual problems with drugs and medical devices. Drug makers Pfizer and Lilly both said their data did not show any causal relationship between hearing loss and the drugs. The FDA said no causal link has been established.
Pfizer vice-president for medical affairs, Dr. Ponni Subbiah, said hearing loss was included in Viagra's adverse events section of its label upon its 1998 FDA approval. It occurred in less than two per cent of patients in clinical trials, which she said was statistically comparable to those in a placebo group.
About 30 million men have taken Viagra since its approval in 1998 as the first widely used drug for erectile dysfunction, according to Pfizer.
- The National Post