Public Citizen, a Ralph Nader organization, on Thursdaypetitioned the FDA to put warnings on all transdermal nicotinepatch products and nicotine gum.
The petition recommends a box warning that states: "(1) Thisproduct has only been shown to be effective when used as anaid to a comprehensive smoking-cessation program and (2)Because it contains nicotine, this product should not be usedwhile the patient is still smoking."
Under FDA regulations, prescription drug products with boxwarnings are not allowed to be advertised on television. Thepetition alleges that advertisements by Marion Merrell Dow,which markets Alza Corp.'s patch, and Ciba-Geigy aremisleading.
"These advertisements create the impression that using thepatch alone is enough to stop smoking. But studies have onlyshown the patch works when it is used as part of acomprehensive treatment plan," said Sidney Wolfe, director ofPublic Citizen's health research group. "Without a supportprogram, many patch wearers will soon find themselveslighting up again -- only this time, $350 poorer."
An Alza spokeswoman said the company couldn't commentwithout first talking to MMD. Alza's clinical trials were done inconjunction with behavior modification.
A third patch, manufactured by Elan Corp. plc, is marketed byAmerican Cyanamid. Cygnus Therapeutic Systems Inc.'s patchwas approved by the FDA earlier this week and will bemarketed by Warner-Lambert Co. Nicorette gum is sold byMarion Merrell Dow.
Elan spokesman Thomas Redington said: "The company believesthat behavior modification is an integral part of a smokingcessation program involving nicotine patches. Our marketingpartner has elected to provide an 800 number for immediatecounseling and referral to professionals, and a compensationprogram for pharmacists to counsel individuals who areprescribed ProStep." -- Karen Bernstein
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