Order Blocking Paxil Ads Is Lifted

A federal judge in Los Angeles has rescinded an order for a temporary injunction that would have barred British pharmaceutical giant GlaxoSmithKline from running television ads for its Paxil antidepressant that said the drug was not habit-forming.

U.S. District Judge Mariana Pfaelzer’s decision Thursday was a victory not only for GlaxoSmithKline but also for the Food and Drug Administration, which had approved the ads. The FDA’s authority as the sole arbiter of accuracy and truth in direct-to-consumer marketing had been challenged by the judge’s original decision to block the ads.

“We are very gratified by the judge’s decision,” FDA spokesman Brad Stone said.

“We are pleased that the judge has reviewed additional scientific evidence and the expert opinion presented by the FDA,” said David Stout, president of US Pharmaceuticals, GSK.

“Experts including the FDA and leading physician and mental health organizations agree that antidepressant medications like Paxil are non-habit-forming.”

The injunction had never gone into effect because Pfaelzer had issued a stay of her order pending further arguments and submissions from the federal government on why Paxil, one of the world’s bestselling drugs, was not habit-forming.

Even though it “strongly disagreed” with the judge’s earlier decision, GlaxoSmithKline voluntarily pulled the ads. The company is now free to run them.

The request for an injunction was part of a class-action lawsuit filed in August 2001 on behalf of 35 former Paxil users from around the nation, who said they suffered withdrawal symptoms such as nausea, fever and electric zaps to their bodies. The suit was filed in Los Angeles because many of the 35 plaintiffs are from Southern California, as is the law firm that is handling the case.

Plaintiffs’ lawyers said Thursday that they were waiting to see the judge’s written opinion and were withholding comment until then.

Justice Department lawyers and the FDA had argued that it was a mistake to say the presence of withdrawal symptoms meant the drug was habit-forming. They said Paxil produced no craving for the drug in its users.

But psychiatrists differed broadly on the question, with some saying they had patients who needed months to get over the drug and others saying the withdrawals were relatively mild in all but a few rare circumstances.

“It was a no-brainer that Paxil is not habit-forming,” said Marc Graff, a psychiatrist and past president of the Southern California Psychiatric Society.

GlaxoSmithKline’s shares rose 71 cents to $40.21 on the New York Stock Exchange.