Judge Bans Some Anti-Depressant Ads
By LOUINN LOTA
Associated Press Writer 08/20/02
LOS ANGELES (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.
