DDMAC untitled letters.

The following untitled letters were issued by the Centers for Drugs' Division of Drug Marketing, Advertising and Communications (DDMAC). Copies are available from our RECORD-RETRIEVE service for $7 plus retrieval. Please reference the MACMIS ID # to order the company response.

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Actelion Pharmaceuticals US, Inc., North Andover, MA, Oct. 30 (DDMAC). The letter stated that a territory manager made "false or misleading oral representations" about the firm's Tracleer (bosentan) tablets concerning its use in treating congestive heart failure (CHF), and failed to discuss risks associated with the product. The agency cited a trial sponsored by Actelion and Genentech which "showed no favorable effect on the primary end-point of all-cause mortality and hospitalization for CHF," and noted "the use of Tracleer for CHF was associated with significant risks." ID# 11014

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Janssen Research Foundation, Titusville, NJ, Nov. 20 (DDMAC). FDA stated promotional materials for Reminyl (galantamine HBr) were misleading in that they claimed the product had a specific benefit linked with vascular dementia in Alzheimer's patients "when none has been demonstrated." The letter stated the study used in the promotion to support these claims "is inadequate for several reasons." The agency cited that in the study two of the patient subgroups were never shown to be clinically distinct from Alzheimer's. Also, while the drug's efficacy was demonstrated in a "mixed dementia" subgroup, "the co-existing Alzheimer's disease in this subgroup may have accounted for all the benefit seen in the study." ID# 10722

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Takeda Pharmaceuticals North America, Inc., Lincolnshire, IL, Nov. 7 (DDMAC). Promotional materials for Actos (pioglitazone hydrochloride) tablets distributed in the exhibit hall of the 2002 American Pharmaceutical Assn.'s annual meeting were misleading in that they omitted safety information critical to appropriate use of the drug, the letter stated. Specifically, FDA stated sales reps distributed promotional materials March 16-19 that made no reference to possible cardiovascular, edema, or hepatic effects. Additionally, the letter stated that distributed materials were outdated. ID # 10933

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Women's Capital Corp., Washington, DC, Nov. 19 (DDMAC). The agency determined the firm's direct-to-consumer (DTC) radio and print ads for Plan B (levonorgestrel), 0.75 mg, emergency contraception tablets were false and lacking fair balance in that they overstated efficacy, failed to convey important limitations on use, and minimize important information about risks associated with the product. For example, the agency took issue with the radio ad stating "[I]t's Jane's lucky day, all right. Because she still has 72 hours after unprotected sex to prevent pregnancy with Plan B emergency contraception," and the print ad stating, "Find out how Plan B, taken within 72 hours of intercourse, can be your back-up plan in preventing pregnancy. And find yourself uttering phrases like 'Phew!'" ID # 11214 DTC, F-B 

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Wyeth-Ayerst Laboratories, Philadelphia, PA, Nov. 5 (DDMAC). The letter objected to the firm's promotional mailers for Suprax (cefixime), stating they were false and misleading. Specifically, FDA objected to claims that Suprax's effectiveness was "Potent. Proven. Practical." Other statements the agency cited were: "When bronchitis hits, help him get Suprax Strong," "Rediscover Suprax (cefixime) and reach 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." Other than disclosing gastrointestinal upset as a side effect, the agency also cited Wyeth for not disclosing other risk information such as hypersensitivity reactions in patients with penicillin allergies, or side effects such as "severe diarrhea and documented pseudomembranous colitis in some patients requiring hospitalization." ID # 11287 F-B

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Xanodyne Pharmacal, Inc., Florence, KY, Nov. 14 (DDMAC). The agency objected to a brochure advertising the company's Methotrexate (methotrexate sodium injection), Leucovorin (leucovorin calcium injection), and Amicar (aminocaproic acid) that failed to provide any risk information about the drugs. According to the letter, Methotrexate "is associated with serious toxic reactions that can be fatal," Leucovorin "may be harmful if given intra-thecally," and Amicar "should not be given when there is evidence of an active intravascular clotting process." Additionally, mailing materials for these chemotherapeutic products did not include risk information or approved labeling. ID # 10894 Lab