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FDA OKs Drug for Kids Despite Justice Probe

Firm wooed docs to illegally prescribe antidepressant: feds

By Matt Cantor,  Newser Staff

Posted Mar 21, 2009 9:42 AM CDT

(Newser) – The FDA has approved an antidepressant called Lexapro for kids, just weeks after the Justice Department accused its maker of marketing it illegally—for kids. Prosecutors say Forest Laboratories for years sweet-talked pediatricians into prescribing Lexapro and the similar Celexa by offering spa visits, event tickets, and fishing trips, even though the drugs hadn't been approved for children, Reuters reports. It's unclear what will come of the charges now.

In the February 25 complaint, prosecutors said Forest had brushed off a negative study and told sales staff to push another with more favorable results. The FDA approval of Lexapro came after new clinical trials, though not all showed success. The FDA reasoned that the drug's effectiveness can be "extrapolated" from adult data. "A lot of these kinds of trials are not successful because it's very difficult to do depression studies," said a Forest spokesman.

Lexapro was approved for teens yesterday by the FDA.
Lexapro was approved for teens yesterday by the FDA.   (Forest Pharmaceuticals)
Lexapro's maker offered incentives for pediatricians to prescribe the previously-unapproved drug in children, prosecutors say.
Lexapro's maker offered incentives for pediatricians to prescribe the previously-unapproved drug in children, prosecutors say.   (Shutterstock)
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COMMENTS
Showing 2 of 2 comments
riffran
Mar 22, 2009 11:44 AM CDT
hey I know that song..lol....Marylin Manson right?....yup ya gotta admit seems to fit the story to a T
Robert_Dada
Mar 21, 2009 3:41 AM CDT
A pill to make you numb, a pill to make you dumb, a pill to make you anybody else. But all the drugs in this world, won't save us from ourselves.

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