MARION MERRELL DOW NICODERM/SELDANE CONSUMER ADS MUST CONTAIN PRECAUTIONS

Executive Summary

MARION MERRELL DOW NICODERM/SELDANE CONSUMER ADS MUST CONTAIN PRECAUTIONS under an agreement with 12 state attorneys general regarding direct-to-consumer advertising for the prescription nicotine patch and nonsedating antihistamine. Marion Merrell Dow reported June 9 that it has agreed to the "assurance of voluntary compliance" and to pay $600,000 to the states ($50,000 each) to cover the costs of the investigation, which began in September 1992. The agreement was reached on June 8 with state attorneys general from Arizona, California, Illinois, Iowa, Massachusetts, Minnesota, Missouri, New Mexico, New York, North Carolina, Texas and Wisconsin. Noting that Marion Merrell Dow "does not admit to any of the allegations" made in the complaint, the agreement states that the company agrees that "revising the format of information in consumer advertising is appropriate." The attorneys general contended in their complaint that consumer ads for the products "have a tendency to mislead consumers, and to create a likelihood of confusion or misunderstanding, in that the advertisements fail clearly and conspicuously to disclose material facts." For example, the attorneys general said, Nicoderm ads did not state that consumers should not use the patch for more than three months or that the effectiveness of nicotine patches has been established only when used as part of a comprehensive behavioral smoking cessation program. The attorneys general also noted that Nicoderm television and radio spots did not mention that the nicotine patch is a drug available only by prescription. Seldane ads did not mention potential health risks such as death, cardiac arrest and ventricular arrhythmias, the state attorneys general maintained. MMD has pulled its direct-to-consumer ads for Nicoderm in favor of alternative marketing strategies. The company reintroduced Seldane-D consumer ads in early April after clearance from FDA's advertising division ("The Pink Sheet" April 19, p. 7). The new Seldane ads bear warnings concerning drug interactions with certain antifungals and antibiotics and advise consumers to see their doctor. FDA required MMD in July 1992 to revise Seldane labeling to include a boxed warning about deaths and cardiac events that had occurred due to drug interactions. The agreement reached with the attorneys general concerning Nicoderm advertising is similar to one signed by Ciba-Geigy for direct-to-consumer ads for its Habitrol nicotine patch in March ("The Pink Sheet" March 22, T&G-6). Under the agreement, Nicoderm consumer ads must include conspicuous statements stating that: the patch will not work for everyone; long-term efficacy of the product has not been established; efficacy has been established only in association with comprehensive smoking cessation programs; patients with certain health conditions, taking other prescription drugs or under doctor's care should discuss the potential risks of nicotine patches with their physician; and the drug is available only by prescription. Marion Merrell Dow also agreed to "develop and make available to the public, either as a package insert or upon request from any consumer, a brief, true and balanced statement in writing containing in plain language" the precautions for Nicoderm use. The company must submit patient information material 45 days following implementation of the agreement. MMD's Seldane consumer advertising program, according to the agreement, must include warning statements about the potential risk of serious cardiovascular events including death, cardiac arrest and ventricular arrhythmias for users of Seldane who concurrently use the antifungals ketoconazole and itraconazole (Janssen's Nizoral and Sporanox); concurrently use the antibiotics erythromycin, clarithromycin (Abbott's Biaxin), or troleandromycin (Roerig's Tao); overdose; or have liver disease. Pregnant women also should be advised to talk with their doctors about the potential risks of Seldane, the agreement states.