FDA OKs Drug for Kids Despite Justice Probe

Firm wooed docs to illegally prescribe antidepressant: feds
By Matt Cantor,  Newser User
Posted Mar 21, 2009 9:42 AM CDT
Lexapro was approved for teens yesterday by the FDA.   (Forest Pharmaceuticals)
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(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.