Released by FDA: 11/5/02.  Posted by FDA:  11/14/02

Diane Mitrione
Assistant Vice President
Worldwide Regulatory Affairs
Wyeth-Ayerst Laboratories
P.O. Box 8299
Philadelphia, PA 19101

RE:   NDA # 50-622
        Suprax (cefixime) Oral
        MACMIS ID # 11287

Dear Ms. Mitrione:

This letter objects to Wyeth-Ayerst Laboratories (Wyeth) dissemination of promotional mailers¹ for Suprax (cefixime) that are in violation of the Federal Food, Drug, and Cosmetic Act (Act) and FDA's applicable implementing regulations.   As a part of the Division of Drug Marketing, Advertising, and Communications' (DDMAC) routine surveillance, we have reviewed these promotional mailers for Suprax; submitted under form FDA 2253, and find them to be false, lacking in fair balance or otherwise misleading, Specifically, we object to the following:

Omission of Facts Material in Light of Representations/Minimization of Risk Information

Promotional materials are false or misleading if they fail to reveal facts material in light of representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials.  Section 201(n) of the Act. Specifically, the promotional mailers present claims and representations concerning Suprax's effectiveness, including but not limited to "Potent. Proven. Practical.," "When bronchitis hits, help him get Suprax Strong," "Rediscover Suprax (cefixime) and reach for potency against acute otitis media,"  "When bronchitis has them feeling weak, Suprax (cefixime) comes on strong," and "Suprax is the choice you want for excellent efficacy." However, with the exception of disclosing that "GI UPSET IS THE MOST FREQUENTLY REPORTED SIDE EFFECT," you fail to present any risk information for Suprax, including the bolded Warning from the PI concerning serious acute hypersensitivity reactions that may occur in up to 10% of patients with a history of penicillin allergy.   Moreover, although you disclose that "GI upset is the most frequently reported side effect," you fail to point out that patients have developed severe diarrhea and documented pseudomembranous colitis with some of these patients requiring hospitalization.

Requested Action

You should immediately cease dissemination of the violative promotional mailers and other promotional materials for Suprax that fail to present important risk information and make the same or similar claims or representations.   Please submit a written response on or before November 19, 2002 describing your intent and plans to comply with the above.   Your letter should include a list of materials discontinued and the date on which these materials were discontinued.

You should direct your response to the undersigned by facsimile at (301) 594-6771, or to the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm 8B-45, 5600 Fishers Lane, Rockville, MD 20857.   We remind you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID # 11287 in addition to the NDA number.

Sincerely;

 

James R. Rogers, Pharm.D.
Regulatory Review Officer
Division of Drug Marketing,
   Advertising, and Communications

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1}   Material ID Codes: 78205-00, 78206-00, 78207-00; and 78191-02