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.
Glaxo also published on its Web site a comprehensive list of the studies it’s conducted on children who used the drug.
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.
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.
“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.”
Eli Lilly & Co.‘s Prozac is the only anti-depressant approved for pediatric use. However, physicians commonly prescribe other antidepressants like Paxil.
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.
Revision date: July 4, 2011
Last revised: by Janet A. Staessen, MD, PhD