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Several pharmaceutical companies received letters in early October from the Food and Drug Administration (FDA) charging that they made misleading marketing claims:
• The FDA has charged Merck and Co. with misleading doctors about its arthritis painkiller rofecoxib (Vioxx) with promotions that downplayed a possible risk of heart attacks. The agency took issue with statements made during company-sponsored audio conferences, in a May 22 press release, and by sales representatives at two medical meetings.
The FDA said the promotions minimized results of the VIGOR (Vioxx Gastrointestinal Outcomes Research) trial, which showed a higher rate of heart attacks among people treated with Vioxx compared with the nonsteroidal anti-inflammatory drug naproxen. Additionally, the FDA said Merck’s materials downplayed a potentially dangerous interaction between Vioxx and the anticlotting drug Coumadin, known generically as warfarin.
In a Sept. 17 warning letter, the FDA ordered the company to stop using some promotional materials and to send a letter to health care providers to correct any false impressions.
• The FDA has ordered Novartis to immediately stop using the "Extend the Reach Patient Starter Kit," which included a patient survey and promotional material about entacapone tablets (Comtan), its Parkinson’s disease treatment.
Some statements in the starter kit "imply that Comtan therapy impacts patient quality of life, overall well-being, and mood, where these outcomes have not been demonstrated with substantial evidence," a letter from the FDA said.
Novartis said in a statement that it thought the claims were appropriate and that the company was working with the FDA to resolve the issue.
• The FDA charged that AstraZeneca made misleading claims in a promotional brochure about the effectiveness of its migraine treatment zolmitriptan (Zomig). The FDA said the brochure included "claims that broaden the efficacy" of Zomig and "imply superiority ... over competitive therapies." Those claims were "not supported by substantial evidence," the agency said in a letter to the company.
These claims included statements such as "reliable in recurrent migraine headaches" and "consistent attack after attack." Another statement said a majority of patients thought Zomig was similar to or better than previously tried migraine therapies.
• The FDA objected to Galderma Laboratories’ dissemination of "violative" promotional materials for adapalene gel (Differin) 0.1%. The ads consisted of two television commercials that the FDA said lacked fair balance because "the communication of important risk information associated with the use of Differin is inadequate."