WASHINGTON (AP) - The Food and Drug Administration alerted physicians
Thursday to rare reports of sudden hearing loss in men taking popular impotence
drugs from Pfizer, Eli Lilly and Bayer.
FDA said it is unclear whether the hearing problems are directly related to
drugs like Viagra, Cialis and Levitra. However, at the agency's request the
drugs' makers added more prominent precautions about hearing loss to product
labels at FDA's request.
Prior labeling for the pills mentioned that hearing problems occured in rare
cases among patients tested with the drugs.
FDA noted that while decreased hearing is common among elders, sudden
hearing loss is highly unusual.
Agency officials said they have received 29 reports of sudden hearing loss
since Pfizer's Viagra, the first impotence drug, was approved in 1998. FDA said
men taking the drugs who experience hearing problems should stop taking them
immediately and seek medical attention.
Pfizer scientists stressed that the problems reported in connection to
Vaigra are extremely rare, with just 11 cases reported in 16,000 patients
studied.
"Based on this data we don't think there's any causal relationship between
Viagra and hearing loss," said Pfizer's Vice President of Medical Affairs Dr.
Ponni Subbiah.
Shares of Pfizer Inc. rose 4 cents Thursday to $25.58 in after hours trading
while Eli Lilly & Co. shares closed down 30 cents to $56.65.
Copyright 2007 Associated Press. All rights reserved. This material may not be
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