UPDATE 1-U.S. FDA: Alcon misleads consumers over ear drops

Thu Apr 28, 2005 05:48 PM ET

(Adds company comment paragraph eight)

WASHINGTON, April 28 (Reuters) - Alcon Laboratories Inc.'s Web page for a version of the antibiotic drug Cipro misleads consumers by making unproven claims about how well it eases ear pain, U.S. health
regulators warned in a letter released on Thursday.

The company, a unit of Alcon Inc. (ACL.N: Quote, Profile, Research) , also did not include any risk information about the antibiotic ear drops, called Cipro HC Otic, on the Web page, the U.S. Food and Drug Administration said.

Alcon sells the drops, which it licensed from Germany's Bayer AG (BAYG.DE: Quote, Profile, Research) , the maker of Cipro.   The drops are approved to treat outer ear infections in adults and youth ages one and older.

On the Web page, Alcon states the drops offer "fewer drops to total pain relief" and a "shorter course to total pain relief." "These claims are misleading because they overstate the efficacy of Cipro HC Otic ... FDA is not aware of substantial evidence or substantial clinical experience demonstrating 100 (percent) pain
relief," FDA officials wrote in the April 27 letter.

The company site also makes readers go to other Web pages not clearly marked to find information on precautions, side effects and other potential problems, the agency said.  Alcon spokesman Doug MacHatton said the company received the letter and would discuss possible changes with the FDA, but he would not
say if the company would immediately change the site.

FDA officials called on Alcon to "cease the dissemination" of the misleading information and told company officials to respond to the warning by May 11.

The Web address cited by the FDA is www.alconlabs.com/us/aj/products/RxTher/CiproHC_ProdPRO.jhtml.


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