Habitrol

In a multi-state court settlement last March, the manufacturer of the Habitrol nicotine patch agreed to provide balanced information about its product to the public. CIBA-Geigy Corporation of Summit, N.J., also agreed to provide $550,000 to 11 states for costs, attorney fees, or consumer education activities.

Minnesota Attorney General Hubert Humphrey III charged that CIBA-Geigy engaged in false advertising and deceptive trade practices by failing to disclose important information about the effectiveness and potential risks of its nicotine patch in consumer advertisements.

Under the settlement, CIBA-Geigy must disclose the following facts in direct-to-consumer advertisements and in a written disclosure statement:

* Habitrol is only an aid to help people quit smoking by reducing nicotine withdrawal symptoms. It has only been shown effective when used as part of a comprehensive smoking cessation program that includes counseling.

* Habitrol won't work for everyone. Effectiveness studies have been limited to three months.

* Habitrol should not be used for more than three months.

* Pregnant women and nursing mothers should talk to their doctors about alternative ways to quit smoking, because nicotine in the patches could harm their babies.

* Consumers with certain health conditions (such as cardiovascular disease), who take other prescription drugs, or who are under a doctor's care should first talk with their doctors about potential risks of nicotine patches.

* Nicotine patch users should not smoke or use other nicotine-containing products while using the patch.

* Habitrol hasn't been studied for use by children or adolescents.

* Habitrol is available by prescription only.

Joining Humphrey in the multi-state settlement were the attorneys general of Arizona, California, Illinois, Iowa, Massachusetts, Missouri, New Mexico, New York, North Carolina, and Texas. The settlement, called an Assurance of Voluntary Compliance, is not an admission of wrongdoing, but is a legally enforceable court order.

(See also "Prescriptions to Help Smokers Quit" in the December 1992 FDA Consumer.)

COPYRIGHT 1993 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group