Family Forum / Parenting / Spanking / June 2004

Glaxo may face prosecution over antidepressant
Sun June 06, 2004 07:49 AM ET

LONDON (Reuters) - GlaxoSmithKline may face prosecution for allegedly not
informing health authorities about suicide risks associated with its
antidepressant Seroxat, The Sunday Times has reported.
Europe's largest drugmaker is already facing charges by New York Attorney
General Eliot Spitzer over the use of the drug, sold in the United States as
Paxil, on children.

The Sunday Times said the Medicines and Healthcare Products Regulatory Agency
(MHRA) had begun an investigation because of fears that Glaxo held back
important information from clinical trials.

The information indicated that Seroxat may cause a greater risk of suicide and
"self-harm" if given to depressed teenagers, the paper said.

A spokeswoman for MHRA -- the government's watchdog on drug safety -- confirmed
it was investigating Glaxo on the Seroxat issue.

"The MHRA treats very seriously any failure to comply with the law. Last year,
MHRA announced that they would investigate (Glaxo) to establish whether they
had complied with their legal obligations under UK and European law," she said.

"The investigation is ongoing and will report shortly," she added. She did not
elaborate.

A Glaxo spokesman declined to comment.

The use of Seroxat and other similar drugs to treat children is under medical
scrutiny because of worries about higher suicide risks, leading U.S. and
British regulators to issue warnings against using it for patients under the
age of 18.

Spitzer filed a lawsuit against Glaxo on Wednesday over charges that it
fraudulently concealed studies showing that the antidepressant may not work
when used to treat children and could lead to suicidal behaviour.

"The company suppressed the negative results of the other studies, which failed
to demonstrate that Paxil is effective and which suggested a possible increase
risk of suicidal thinking and acts," Spitzer said. This amounted to "repeated
and persistent fraud," he said.

Glaxo spokeswoman Mary Ann Rhyne said on Wednesday that the company
disseminated information about all its trials either in medical journals or at
public scientific meetings as well as to regulatory agencies.

The Sunday Times said the MHRA may choose to prosecute Glaxo or go after
specific individuals at the company.



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