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Pharmaceutical groups told by FDA to toughen impotence drug warnings


Published :
Fri, 19 Oct 2007 18:31
By : Agencies
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WASHINGTON (Thomson Financial) - 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.'

Viagra is made by Pfizer Inc, Cialis by Eli Lilly and Co and Levitra by Bayer AG.

Revatio, also made by Pfizer and which is used to treat pulmonary hypertension, 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.

tf.TFN-Europe_newsdesk@thomson.com

wj

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Copyright Thomson Financial News Limited 2007. All rights reserved.

The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.




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