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Lawsuit Targets Maker of Paxil

65 Coloradans say they weren't told of withdrawal risk

Dec 3, 2003 | Rocky Mountain News

Sixty-five Coloradans sued the maker of the antidepressant Paxil in federal court Friday, claiming the company failed to warn them that the drug can produce dependency, addiction and painful withdrawal symptoms.

"That's absolutely not true," said Mary Anne Rhyne, spokeswoman for British-based Paxil maker GlaxoSmithKline.

"We have had in our label language discussion of symptoms that can occur upon discontinuing Paxil for quite some time," Rhyne said.

"You can experience symptoms, as you can with other

SSRIs and as you can with other kinds of medicines as well."

Paxil is a type of antidepressant known as a selective serotonin re-uptake inhibitor (SSRI). It is related to such antidepressants as Prozac and Zoloft.

"For the most part the symptoms are mild to moderate, and temporary," Rhyne said.

The Colorado lawsuit, filed in Denver U.S. District Court as a proposed class action, said the company's advertisements state falsely that Paxil is not habit-forming.

No package insert warns that Paxil can cause nausea, anxiety, dizziness, sensory disturbances, headaches, vision distortion, sweating, agitation, fatigue, tremor, sleep disturbances including intense dreams, confusion, palpitations, insomnia, irritability and digestive disorders, the lawsuit said.

It said all the plaintiffs took Paxil under doctors' prescriptions. When they reduced their dosages or stopped taking the drug, they suffered one or more of the withdrawal symptoms.

"These reactions were unexpected by plaintiffs and their physicians and plaintiffs would not have taken Paxil if they had known about Paxil's general habit-forming nature and ability to cause withdrawal symptoms," the lawsuit said.

It said GlaxoSmithKline's labeling on Paxil in other countries warns that abruptly discontinuing the drug can cause the withdrawal symptoms.

The lawsuit seeks damages and court orders restricting advertising claims about Paxil.

The plaintiffs come from all over Colorado, including the Denver area, Grand Junction, Trinidad, Colorado Springs, Steamboat Springs, Pueblo, Greeley, Lamar, Durango, Salida, Fort Morgan and Cortez.

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