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GlaxoSmithKline''s biggest selling product used to be its antidepressant drug Paxil. Over the years, the safety of Paxil has been questioned, and Paxil was never FDA approved for patients younger than the age 18 because of studies showing it was not effective. Over the years, adults using Paxil have filed lawsuits over adverse side effects and withdrawal problems. Now Glaxo is facing a number of lawsuits from U.S. parents of children and adolescents given Paxil after making claims the company has suppressed data showing the drug increased suicidal tendencies in young people.
In the last year, evidence has surfaced suggesting a possible link between antidepressant treatments with not only Paxil, but also Celexa and Zoloft, and an increase in suicide risk. The concealment of the Paxil information has left more questions that just its safety. Questions about the drug manufacturers ability to effectively conceal study results that find potentially harmful effects have resulted in criticism against drug manufacturers and against regulators failing to provide adequate drug regulation.
The drug company has denied covering up this information, and the pharmaceutical industry has been widely criticized for failing to make clinical trial results readily available with fear that negative results would be bad publicity. New York Attorney General Eliot Spitzer has accused Glaxo of withholding negative information about Paxil and the drug company settled the case in August for $2.5 million, a surprisingly small sum that shocked people.
The number of U.S. children taking antidepressants has more than doubled since the early 1990s. This is around the time when the SSRI class of antidepressant drugs (Celexa, Paxil, Prozac and Zoloft) replaced older antidepressants in its widespread use. In 2002, an estimated 2.1 million Paxil prescriptions were written alone.
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