- NEW YORK -- GlaxoSmithKline
PLC, which is being sued for allegedly concealing negative information
on the effects of its Paxil anti-depressant on children, admitted this
week that the drug didn't show a benefit over a sugar pill when treating
depression in children.
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- Glaxo also published on its Web site a comprehensive
list of the studies it's conducted on children who used the drug.
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- The British company said that Paxil led to a few more
incidents possibly linked to suicidal behavior than a placebo did, though
none of the children in its studies actually committed suicide.
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- The move to release the results of the past trials at
one time and in one place comes after New York Attorney General Eliot Spitzer
filed a consumer-fraud lawsuit last Wednesday accusing Glaxo of "repeated
and persistent fraud" for concealing details on how well the drug
works and its side effects.
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- "We feel like we've acted appropriately in communicating
the data from the (Paxil) trials," Glaxo spokeswoman Mary Anne Rhyne
said. "Posting the information was in the interest of full disclosure."
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- Eli Lilly & Co.'s Prozac is the only anti-depressant
approved for pediatric use. However, physicians commonly prescribe other
antidepressants like Paxil.
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- On Friday, the FDA admonished Glaxo for running a TV
ad for Paxil CR, the controlled release version of Paxil, that was "false
or misleading" because it suggests the drug can be used by a broader
range of patients than it is actually approved for.
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