2 Over-Counter Nicotine Patches Get Key Backing

A federal advisory committee recommended Friday that the Food and Drug Administration approve the over-the-counter sale of Nicotrol, the nicotine transdermal patch made by Pharmacia & Upjohn Inc., and Nicoderm, made by Alza Corp. and Germany’s Hoechst.

Nicotrol, used to ease the withdrawal symptoms of stopping smoking, is now sold only through prescription by McNeil Consumer Products, a unit of Johnson & Johnson.

The FDA usually accepts the recommendations of its advisory committees but is not bound by them.

Analysts said they did not know what effect, if any, nonprescription availability would have on the sales of the nicotine through-the-skin patches, which are already widely prescribed by doctors.

But sales could be spurred with aggressive advertising, they added. Medical experts said over-the-counter sales, if approved by the FDA, would be limited to people 18 or over, the minimum age required to buy cigarettes.

Skin patches, which administer controlled doses of nicotine to ease withdrawal symptoms, cost about $250 for a 10-week supply, considered enough to wean someone off cigarettes if the smoker is intent on stopping.

The Nonprescription Drugs Advisory Committee’s action came as the Clinton administration is in a fight with the tobacco industry over proposals to regulate cigarette sales, especially to younger people.

Some states have already filed lawsuits against the industry to recoup health expenses incurred in treating diseases caused by tobacco smoke.

Medical experts said there is no evidence that the nicotine from the patches caused any greater risk of heart attack than cigarette smoking.

Nicotrol was approved as a prescription drug in the United States in 1992. Nicoderm has been sold by prescription in the United States since 1991.