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N.Y. Charges Maker Hiding Paxil's Risks to Teenagers

June 03, 2004|From Newsday

NEW YORK — State Atty. Gen. Eliot Spitzer filed a lawsuit Wednesday charging one of the largest pharmaceutical companies in the world with hiding significant information about the benefits and risks of its antidepressant medicine Paxil for use in teenagers.

The drug has been banned in England and other countries because of concern about side effects including violence and suicidal thoughts and behavior. In the United States, a strong federal warning was issued last June about its use by children. In 2002, more than 2 million prescriptions for Paxil were written for children in the United States.

The lawsuit, the first of its kind from a state attorney general, alleges that GlaxoSmithKline engaged in "repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil."

The only antidepressant medicine approved for children is Prozac, yet once a medicine is federally approved for adults it can be used "off label" for any medical or psychiatric condition, including use in children.

The attorney general's office contacted the pharmaceutical company last October and asked for all studies about Paxil. Some studies had not been published, according to Spitzer, and showed that the drug didn't work better than a placebo.

Joseph Baker, chief of the attorney general's healthcare bureau, said a possible link to suicidal thinking and acts also had been concealed.

The pharmaceutical company released a statement Wednesday that said it "has acted responsibly in conducting clinical trials in pediatric patients and disseminating data from those studies.... All pediatric studies have been made available ... worldwide."

Baker cited company documents concerning increased risk in suicidal thoughts "and decided to release only the studies with more positive results ... to minimize any potential negative commercial impact."

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