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Executive Summary

NICOTINE PATCH ADVERSE REACTIONS ARE ON FDA DRUG ABUSE COMMITTEE's AGENDA for its July 14 meeting, according to an amended Federal Register notice scheduled to be published July 6. The committee originally planned to discuss only pregnancy categories for nicotine products ("The Pink Sheet" June 29, In Brief), but will now have a more general labeling discussion in light of recent reports of heart attacks in patients simultaneously smoking and using patches. * The committee will also discuss Public Citizen's Health Research Group April 30 petition asking that manufacturers be required to add a boxed warning to nicotine patch labeling stating that they are meant for use as part of a comprehensive smoking cessation program ("The Prink that they are meant for use as part of a comprehensive smoking cessation program ("The Pink Sheet" May 4, T&G-3). The advisory committee will meet as nicotine patch marketers are preparing a second wave of promotions for the products. Acceptance by FDA of HRG's petition would derail those plans: if FDA were to relabel the products to include a boxed warning, direct-to-consumer ads would not be allowed. While patch companies have stopped DTC ads for the time being as a result of product shortages, the upcoming launch of Warner- Lambert/Cygnus' Nicotrol-16 in mid-July coupled with increased supplies of other patches will likely touch off renewed campaigns. Marion Merrell Dow, marketer of Alza's Nicoderm, is reported to be planning to launch a major new campaign in mid- to late-summer (see following T&G). Other patches are marketed by Ciba-Geigy (Habitrol) and Lederle (Elan's ProStep). The companies are investigating the heart attack reports, which so far are confined to five incidents documented by one hospital ("The Pink Sheet" June 22, In Brief). In a June 24 meeting with the New York Society of Security Analysts' Health Care Group, Alza President Jane Shaw, PhD, estimated that more than 1 mil. people have tried the patches. Nevertheless, she added, the possibility that smoking while using the patch increases a smoker's already elevated risk for a heart attack "will have to be looked at very carefully." Alza's Shaw pointed out that Nicoderm is the only patch whose labeling includes clinical trial data on patients with preexisting coronary artery disease. There is "a chance we can differentiate our patch here," Shaw maintained. Ciba-Geigy said it is conducting a clinical trial in Israel of CAD patients. At least four of the reported heart attacks apparently occurred in patients using Habitrol (which is the market leader with sales in excess of $335 mil. so far). Ciba-Geigy said it is studying how the negative publicity about heart attacks has affected consumer perceptions of the patches. Shaw asserted that it is unlikely that FDA will seek to change the label for the patches to contraindicate their use in patients with serious risk of heart attacks. Pilot Drug Evaluation Staff Director John Harter, MD, "will fight that," she claimed, because he strongly believes those patients need the products. A discussion paper that the Pilot Drug Staff prepared for the July 14 advisory committee bears out Shaw's point. "Since smoking cessation can be of benefit to high-risk patients, further evaluation of nicotine products should not be discouraged in this population," the paper states. "High-risk patients...are not being considered contraindications for the approved nicotine substitution products, as they were at the time of the initial approval [in 1985 of Marion Merrell Dow's] Nicorette gum," the paper says. "This issue was considered by the Drug Abuse Advisory Committee (May 10, 1991) and the consensus supported removing these high risk groups, who could benefit the most from smoking cessation, from contraindications." The discussion paper notes that FDA has reviewed clinical trials of subjects with "non-severe, asymptomatic cardiovascular disease, peripheral vascular disease, hypertension, diabetes mellitus, chronic obstructive pulmonary disease or allergy," including the Alza CAD trial. "None of the clinical studies reviewed...showed serious disease-related complications," the paper says. The Drug Abuse Advisory Committee also agreed at its May 10, 1991 meeting that smoking "reduction" as opposed to "cessation" is not a suitable indication for nicotine-substitution products, according to the paper.

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