A federal judge has ordered the pharmaceuticals company GlaxoSmithKline to stop saying in its advertisements for Paxil, a top-selling antidepressant, that the drug is "nonhabit-forming."
The decision, which was issued Friday by Judge Mariana R. Pfaelzer of the United States District Court in Los Angeles but lawyers only talked about this week, was one of the first significant rulings on prescription drug advertising. It has caused the Food and Drug Administration, which regulates drug advertising, to file papers with the court, asking it to reconsider.
The agency said it had reviewed the Paxil ads and had agreed that the drug company could make the "nonhabit-forming" claim. The agency's lawyers said they were concerned that the decision, which was based in part on California law, could lead to a situation where there could be different requirements for drug advertising in each of the 50 states.
In issuing the order, which takes effect Sept. 1, Judge Pfaelzer granted a request made by lawyers representing patients who said they suffered severe nausea and myriad other problems when they tried to stop taking the drug. The lawsuit, which seeks class-action status, contends that GlaxoSmithKline did not warn patients of problems that could arise if they stopped taking Paxil.
Karen A. Barth, a Los Angeles lawyer who helped file a lawsuit against the company last August, said that patients, doctors and other health care providers had filed thousands of reports with the F.D.A. describing patients' reactions after they tried to stop taking Paxil.
One patient, Dolores Phillips, an environmental lobbyist from Princeton, N.J., said she tried for three years to stop taking Paxil. Each time she reduced the dosage, Ms. Phillips said, she suffered from severe nausea, sleeplessness and tremors in her arms and legs. She said the nausea became so bad she was forced to go to a hospital emergency room.
"It was just an awful experience," Ms. Phillips said. "No one should have to go through it. These drugs are being prescribed as if they are antacids and they're not."
Ms. Phillips says she was able to stop taking Paxil by switching to another antidepressant. She hopes to stop taking that drug eventually.
With the help of an aggressive television and print ad campaign, Paxil was the second-best-selling antidepressant last year, with sales of $2.2 billion, according to IMS Health, a consulting firm. The best-selling antidepressant was Zoloft from Pfizer.
GlaxoSmithKline said yesterday that it planned to appeal Judge Pfaelzer's decision.
David Stout, president of the company's pharmaceutical business in the United States, said in a statement that GlaxoSmithKline "strongly stands behind the safety and efficacy of Paxil."
"Physician organizations like the American Psychiatric Association have stated that antidepressants are not habit-forming," Mr. Stout said.
In December, GlaxoSmithKline added a precaution to Paxil's label urging patients not to abruptly stop taking the drug. The precaution said that if the dose could not be gradually reduced without the patient's experiencing withdrawal symptoms, the patient might have to return to taking the original dose.
Both the company and the F.D.A. say that many drugs cause problems when patients stop taking them, but that does not mean that a drug should be considered addictive or habit-forming.
"These problems are just the body's adjustment when you stop taking medicines," a spokeswoman for GlaxoSmithKline, Mary Anne Rhyne, said. "It takes more than that to be addictive."
For example, Ms. Rhyne said, Paxil does not cause patients to crave the drug or feel they need a higher dose.
Dr. Stuart Shipko, a psychiatrist in Pasadena, Calif., who was an expert witness for the patients' lawyers, said that all the newer antidepressants appeared to cause problems for many patients who tried to stop taking them, but that Paxil appeared to cause the most severe effects.
"The commercials make it seem as if this pill is a life enhancer," Dr. Shipko said. But then people try to stop taking it, he said, and they cannot stop. "The longer you take it, the harder it is to stop," he said.
Melody Petersen, The New York Times. August 21, 2002
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