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Glaxo Gets OK for Ads Claiming Paxil Not Addictive

Posted by Rick on October 12, 2002, at 20:30:11

Thought Babblers might be interested in the following item from Reuters Medical News:

Glaxo Gets OK for Ads Claiming Paxil Not Addictive

LOS ANGELES (Reuters) Oct 11 - A US judge on Thursday told GlaxoSmithKline Plc, Europe's biggest drug maker, that it can claim its anti-depressant Paxil is not addictive.
US District Judge Mariana Pfaelzer rejected a request by attorneys for a group of Paxil users that advertisements stating that Paxil is "non-habit forming" be permanently barred.

Last month, Pfaelzer had granted a temporary injunction against the ads, but she delayed the start date of the order until after hearings held this week.

The Paxil users are suing the British-based drug maker in federal court in Los Angeles, claiming that it deliberately played down the severity of withdrawal symptoms associated with abruptly stopping the drug.

A hearing on a bid to certify the case as a class-action lawsuit has been scheduled for Nov. 18, according to Glaxo.

"We are extremely pleased with the ruling," company spokesman Michael Fleming said, adding that Glaxo has not yet decided whether to resume running ads that say Paxil is non-habit forming.

Glaxo last month launched a new ad campaign for Paxil CR, a sustained-release formulation of the drug, that does not include references to whether the drug is habit forming.

The company was supported in court by the US Food and Drug Administration, which said it had previously reviewed in-depth Paxil's side effects and concluded that the drug is not habit forming and, as a result, the ads did not mislead.

The agency also asked that the court reject the plaintiff's argument because the FDA's authority over prescription drug advertising preempts that of the federal courts.

Paxil, Glaxo's top-selling product, reached sales of $2.7 billion last year.



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URL: http://www.dr-bob.org/babble/20021012/msgs/123399.html