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Tennesseans File Paxil Suit

Jun 4, 2003 | Nashville City Paper,

Nearly 40 Tennesseans have filed suit against pharmaceutical giant GlaxoSmithKline, charging the company did not properly inform patients of potential addictive side effects of the antidepressant drug Paxil.

The suit, filed recently in Middle Tennessee’s U.S. District Court, asks Federal District Court Judge Todd Campbell to award damages of at least $1 million per plaintiff to individuals who say they suffered adverse physical and psychological effects akin to withdrawal symptoms when they stopped using Paxil, but had not been previously warned by the makers of the drug that such effects were possible.

Legal documents state that GlaxoSmithKline knowingly marketed Paxil in the United States as a drug with “mild†side effects when they actually knew that side effects could be severe. In addition, the suit claims that the company intentionally labeled what plaintiffs say can be acute withdrawal symptoms as “discontinuation†symptoms, in order to downplay the effects of the drug.

The suit is one of several federal lawsuits that have been filed since August 2001 in numerous states across the country against GlaxoSmithKline charging that the European company, which also markets such drugs as Advair, Imitrex, Valtrex, Tums and Nicoderm CQ, did not include in its list of potential side effects the possibility that patients could suffer withdrawal symptoms such as nausea, anxiety, dizziness, agitation, tremor, palpitations and sleep disturbances after discontinuing the drug.

Paxil, a selective serotonin reuptake inhibitor (SSRI) of the same class as Zoloft and Prozac, was introduced as a prescription antidepressant medication in late 2002. This most recent suit claims that medical experts in the United States and Great Britain have reported the potential withdrawal side effects of the drug since nearly the month it hit the market. Some experts have reported that adverse withdrawal symptoms to Paxil were reported in 30 percent to 40 percent of subjects tested, and were markedly worse than withdrawal symptoms reported for Prozac or Zoloft by as much as 4-to-1.

The suit claims that the fact that Paxil was not administered with any warning of potential withdrawal connotes false and misleading advertising as well as irresponsible marketing of a product on the part of GlaxoSmithKline, who, attorneys say, did not even perform any internal, ongoing studies into the potentially addictive side effects of the drug.

GlaxoSmithKline has publicly denied charges that Paxil may be addictive since the filing of the first charges in 2001. Company representatives did not return phone calls Tuesday by press time.

The company’s Web site acknowledges possible side effects that Paxil users might experience while taking the drug, characterizing them as “mild to moderate,†which include constipation, decreased appetite, insomnia, nervousness and others.

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