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Judge: Paxil Ads 'Misleading'
August 20, 2002
(AP) A federal judge ordered the maker of the popular anti-depressant Paxil to halt all television commercials nationwide that claim the drug is not habit forming.
The ruling against GlaxoSmithKline comes about a year after a class-action lawsuit was filed on behalf of 35 patients who claimed they suffered withdrawal symptoms such as nausea, fever, and "electric zaps" to their bodies.
U.S. District Judge Mariana Pfaelzer found that in other countries, labels on the drug warn of adverse reactions when use of the drug is discontinued.
The commercials were "misleading and created inaccurate expectations about the ease of withdrawal from the drug," Pfaelzer ruled Monday.
Company attorneys are appealing.
"The U.S. Food and Drug Administration and not the courts has the expertise and responsibility for reviewing and regulating pharmaceutical ads," David Stout, president of U.S. Pharmaceuticals at Paxil's producers, GlaxoSmithKline, said in a statement.
"The Paxil television ad was submitted for FDA review prior to use, and the agency raised no objections to the language at issue," Stout said.
The plaintiffs' lead attorney, Karen Barth, said GlaxoSmithKline changed its labeling on Dec. 14 but continued to run commercials and distribute brochures saying Paxil "may cause mild, usually temporary side effects in some individuals."
Plaintiffs' attorneys said a hearing was set for Oct. 7 to decide whether the lawsuit should be converted to a nationwide class-action.
The ads also said "Paxil has been studied both in short-term and long-term use and is not associated with dependence and addiction."
Surging U.S. sales of Paxil and the asthma drug Advair led a 15 percent increase in second-quarter profits for London-based GlaxoSmithKline PLC. Global sales of Paxil grew 29 percent.
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