Glaxo faces Seroxat fraud lawsuit

June 7, 2004

Seroxat manufacturer, GlaxoSmithKline, is facing fraud charges in the United States for allegedly concealing information that the SSRI antidepressant caused suicidal behaviour among children and teenagers during clinical trials, societyguardian.co.uk has reported.

The civil lawsuit, filed by New York State attorney general Eliot Spitzer, claims that the company suppressed the results of at least four studies that showed Seroxat was at best no more effective than a placebo and at worst was harmful. At the same time the company was said to be promoting the drug heavily to American doctors boasting of its efficacy and safety.

Mr Spitzer said the company had "engaged in repeated and persistent fraud", reported societyguardian.co.uk

Societyguardian.co.uk reported the lawsuit alleges that five studies conducted by GSK between 1998 and 2002 raised serious questions about the efficacy of Seroxat (called Paxil in the US) and in some cases increased the likelihood of suicidal behaviour.

In the UK, the Medicines and Healthcare Regulatory Agency (MHPRA) is reviewing Seroxat and other SSRIs.

The lawsuit says GSK submitted the unpublished results to regulators in 2002, four years after the first negative results appeared, when it hoped to win approval for the treatment of obsessive-compulsive disorder with Seroxat..

The MHPRA was finally given the full trial data on May 27 last year. Two weeks later it announced it was effectively banning the use of Seroxat in children. Following further investigations by the expert group, every other SSRI except Prozac has also been effectively banned from use in children.

A GSK spokesman has denied a cover-up.

See full societyguardian.co.uk article

See:
April 4, 2004: GPs 'forced' to overprescribe antidepressants - survey shows 80% of doctors believe they are writing too many prescriptions for SSRIs
March 28: SSRI antidepressants must carry warnings that people might become suicidal while taking them - US drug regulator states
March 21: Chief exec of Medicines and Healthcare Products Regulatory Agency criticises charity director for provoking "alarm" and "confusion" over antidepressant safety - Richard Brook faces rebuffal after accusing Committee of Safety on Medicines group of negligence over its investigations into SSRI antidepressants.
March 15: MIND's chief executive resigns from expert group reviewing safety of antidepressants - Richard Brook accuses regulatory agency of negligence
Feb 8: GlaxoSmithKline 'held back' data on SSRI anti-depressants for children - latest developments in the SSRI controversy. Plus, advisers to the US Food and Drug Administration warn that SSRIs may increase suicidal thinking among children.

Add your comments
What do you think? Email your comments on the above
article to the editor using the form below. Selected comments will be displayed.

© 2001-7  Psychminded Limited. All rights reserved