GlaxoSmithKline is facing a class action lawsuit in the USA from some of its shareholders, which claims that the company issued “false or misleading public statements” and “improperly concealed deficiencies” about its controversial antidepressant, Paxil/Seroxat (paroxetine).
The suit has been filed on behalf of people who bought GSK shares between February 21, 2001 and August 5, 2004 and in particular alleges that the company had been less than open with its data before a link came to light between selective serotonin reuptake inhibitors, such as Paxil, with suicidal tendencies in adolescents.
The US Food and Drug Administration subsequently ordered that all antidepressants be stamped with a black box warning of an increased risk of suicidal behaviour among youngsters [[18/10/04b]].
GSK is no stranger to the courts when it comes to Paxil and several suits have already been filed against the company [[07/09/04a]], most notably last year by New York attorney general Eliot Spitzer who claimed that GSK had been withholding negative information about Paxil and its effects on adolescents and children since 1998 [[03/06/04a]].
Almost immediately after that case, GSK came out fighting and published all its study data relating to the use of Paxil in children and adolescents [[17/06/04b]]. The company has yet to comment on the shareholder lawsuit but must be wondering when the drug will drop out of the headlines. Just last month, the FDA seized batches of Paxil and diabetes medicine Avandamet (rosiglitazone/metformin) from GSK’s Cidra plant in Puerto Rico after they failed to meet manufacturing standards [[07/03/05a]].