Alcon Labs, Forth Worth, TX, April 27, (DDMAC).In a review of Alcon's website regarding Cipro HC Otic otic (ot´ik) auditory (1).o·tic adj. Of, relating to, or located near the ear; auricular. Otic Pertaining to the ear. (ciprofloxacin hydrochloride and hydrocortisone hydrocortisone (hī'drəkôr`tĭzōn'), another name for the steroid hormone cortisol, more especially used to refer to preparations of this hormone used medicinally. otic suspension), CDER's Division of Drug Mar keting, Advertising and Communications (DDMAC DDMAC Division of Drug Marketing, Advertising and Communications ) concluded that the advertisement found on the site was misleading because it failed to reveal important risk information, overstated the efficacy of the drug and made unsubstantiated superiority claims. According to the FDA-approved product labeling (PI), Cipro HC Otic is indicated for the treatment of acute otitis externa. The website failed to reveal contraindications and risks in patients with hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to hydrocortisone, ciprofloxacin ciprofloxacin /cip·ro·flox·a·cin/ (sip?ro-flok´sah-sin) a synthetic antibacterial effective against many gram-positive and gram-negative bacteria; used as the hydrochloride salt. cip·ro·flox·a·cin n. and the quinolone class of antimicrobial agents, the agency noted. Additionally, the site overstated the efficacy of the product by claiming "Fewer drops to total pain relief' and "Shorter course to total pain relief," which suggests 100% pain relief when using the product. Unsubstantiated superiority claims included such statements as: "Cipro HC Otic Ends the Pain 19 Hours Sooner." The website did not specify what comparison products require 19 additional hours to "end pain." DDMAC previously objected, in an untitled letter dated July 18, 2003, to these same claims and omitted risks. F-B F-B Forward - Backward (radar image analysis) ; Doc. 13440W Alcon Labs: [check] Failed to reveal important risk information for Cipro HC Otic (ciprofloxacin hydrochloride and hydrocortisone otic suspension [check] Overstated the efficacy of Cipro HC Otic [check] Made unsubstantiated superiority claims |
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