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DrugScreening.org


 

Patch Makers Say FDA Rules Prevent Use
March 9, 2007

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News Summary

Drug makers are complaining that federal regulations are preventing more widespread adoption of stop-smoking products like nicotine gum, the Wall Street Journal reported Feb. 27.

One in four Americans thinks that nicotine gum and similar products are just as dangerous as smoking, studies show. Observers note that the warning on a box of nicotine gum is 20 times longer than that on a pack of cigarettes, and some public-health experts say that warnings against use by pregnant women should be relaxed. Moreover, they say, adolescents should be allowed to use nicotine-replacement therapies (NRTs) without a doctor's prescription.

"A 17-year-old smoker of 25 cigarettes per day is doing the right thing to use nicotine gum," said tobacco researcher Jonathan Foulds of the University of Medicine and Dentistry of New Jersey. "Why give him another hurdle to cross to get help?"

Health officials persuaded the Food and Drug Administration to allow over-the-counter sales of cessation products in 1996, and in 2000 the agency began advising the use of the products for most people trying to quit smoking. But the effort to ease the warnings may cause opposition, especially since recent studies suggest that the products have only been marginally effective in helping smokers quit.

"The use of nicotine, whose efficacy in treating nicotine addiction is controversial even in adults, must be strictly avoided in pregnancy, breastfeeding, childhood and adolescence," stated an editorial in the current Journal of Health Psychology.

British health officials, however, recently eased warnings on NRT products. Saul Shiffman, a GlaxoSmithKline consultant and University of Pittsburgh professor of psychology and pharmaceutical science, said that fear driven by the warning labels could explain why people are "continuing to use their cigarettes rather than the medicine to help them quit." 

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