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Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation


Mass. group sues Paxil drugmaker

By Ellen Barry
Globe Staff

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A group of Massachusetts plaintiffs filed a class-action suit earlier this month against the maker of the blockbuster antidepressant Paxil, alleging that withdrawal from the drug brought on such ill effects as nausea, sweating, agitation, tremors, insomnia, dizziness, and the sensation of electric ''zaps'' in the brain.

The lawsuit, filed Oct. 9 in Suffolk Superior Court, is part of a multipronged legal challenge to Paxil, taken by millions of people in the United States alone. It joins a nationwide class-action suit and nine other statewide lawsuits in asserting that GlaxoSmithKline, which manufactures Paxil, intentionally misled physicians and consumers about the drug's ''addictive'' qualities - an allegation that was denied yesterday by the company and the physicians who recommend it.

Paxil is one of a multibillion-dollar class of drugs - including Prozac and Zoloft - that relieve depression by building up levels of the neurotransmitter serotonin around nerve endings in the brain. Called selective serotonin reuptake inhibitors, or SSRIs, the drugs have succeeded in large part because they lack the serious side effects of earlier treatments for depression and anxiety, including habituation. And although previous lawsuits have alleged that SSRIs can spur violence, they have had little effect on the drugs' enormous popularity.

Sales of Paxil, which received FDA approval in 1992, lagged for years behind competitors Prozac and Zoloft, but have benefited from the expiration of Prozac's patent and by its increasing use for anxiety disorders. Last year it was GlaxoSmithKline's top-selling drug, netting the company $2.7 billion, a spokesman said.

The company acknowledges that there are side effects to the ''discontinuation'' of Paxil, including dizziness and occasionally abnormal dreaming and the sensation of electric shocks, but most last no longer than two weeks, said spokeswoman Mary Anne Rhyne. Rhyne added that ''any claims that Paxil is addictive are without foundation.''

But Janelle Leonard, a Bradford schoolteacher, said neither she nor her doctor were prepared for what happened when she decided to stop taking Paxil. Only when she accessed Internet chatrooms - where dozens of people compared their experiences upon going off Paxil - did she realize where her disabling symptoms were coming from.

''Nobody had told me it was habit-forming,'' said Leonard, who is 30. ''I ended up really ill ... I was bedridden, sick. I had insomnia. I was paranoid, and I was still sick to my stomach. I had diarrhea. I couldn't leave the house.''
So far, 6,000 would-be plaintiffs have contacted the Los Angeles law firm that filed the nationwide lawsuit, and 1,000 have been confirmed as plaintiffs, said Karen Barth, lead counsel for Baum, Hedlund, Aristei, Guilford & Schiavo. The nationwide lawsuit will reach the certification phase on Nov. 18, and attorneys plan to file lawsuits in all 50 states in case the nationwide suit does not go forward, she said.

The suit had resulted in an injuction against GlaxoSmithKline not to advertise Paxil as ''nonhabit-forming.'' The judge rescinded her order Oct. 11, after the Food and Drug Adminsitration determined that the ads were not misleading.
Barth's law firm has brought previous class-action suits on behalf of the families of patients who committed suicide while taking Paxil, Prozac, or Zoloft - but the suicides have been so rare that they have had little ripple effect on the public, she said.

A lawsuit based on the effects of withdrawal may have more traction, because the experience is far more widespread, said Dr. Joseph Glenmullen, a Harvard University psychiatrist and author of ''Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and other Antidepressants with Safe, Effective Alternatives. ''

''You have countless individuals who have terrible experiences. Too many doctors have seen this, it's too undeniable. Too many patients are very, very upset by it,'' Glenmullen said.

But several psychopharmacologists interviewed said they rejected offhand the idea that SSRIs are addictive. Although the brain does adapt to SSRIs, the term ''addiction'' suggests craving, intoxication, or an increased tolerance that requires ever-higher doses, none of which have been documented with Paxil, said Dr. Alexander Bodkin, a research psychiatrist at McLean Hospital.

''Insulin is habit-forming. Digitalis is habit-forming,'' said Dr. William Appleton of Harvard University. ''Exercise is habit-forming, but no one ever brings a class-action suit against that.''

But perhaps, Appleton said, the lawsuit is just part of a predictable backlash against SSRIs, which were greeted as wonder drugs a decade ago.
''One of the interesting things about drugs is they're a little bit like shopping centers,'' said Appleton, author of ''Prozac and the New Antidepressants. '' ''They come in clean and brand-new and full of hope,'' he said. ''They go out old and tired and dirty.''

This story ran on page A3 of the Boston Globe on 10/26/2002.
© Copyright 2002 Globe Newspaper Company.