FDAnews Drug Daily Bulletin

Alcon Gets Warning Letter for Misleading Statements About Cipro HC Otic

May 11, 2005

Alcon Laboratories' website for Cipro HC Otic eardrops fails to disclose risk information and overstates the efficacy of the product, according to an FDA warning letter.

The warning letter criticized Alcon for not making risk information about Cipro HC Otic (ciprofloxacin HCl/hydrocortisone otic) readily accessible on its website. The drug's risks include potentially fatal skin reactions.

"Your website fails to present any risk information within the body of the main ... page on the website," states the warning letter issued by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). "One must navigate to other pages ... to obtain risk information. Furthermore, once the viewer reaches the [appropriate pages], the risk information is listed at the end of the page without any headers or other signals to indicate to the reader that it is important risk information."

DDMAC also took exception to language on the website that suggested Cipro HC Otic offers a "shorter course to total pain relief." That claim is misleading and overstates the efficacy of the drug, DDMAC said.

To view the warning letter, go to http://www.fda.gov/cder/warn/2005/Cipro-13122.pdf (http://www.fda.gov/cder/warn/2005/Cipro-13122.pdf).