June 12, 2008 / 4:00 PM / 11 years ago

UPDATE 3-US senator seeks FDA probe of Glaxo's Paxil data

(Adds scientist comment, report details)

WASHINGTON, June 12 (Reuters) - U.S. Sen. Charles Grassley asked regulators on Thursday to investigate whether drugmaker GlaxoSmithKline Plc (GSK.L)(GSK.N) withheld data about a risk of suicide linked to its anxiety disorder drug Paxil.

Grassley, a Republican from Iowa, said in a letter that a British regulatory agency had found that Glaxo knew as far back as 1998 that Paxil was associated with a higher risk of suicidal behavior in adolescents.

“I would like you to take a look at the information that agency gathered and determine if the company has withheld safety information here as well,” Grassley wrote in the letter to the heads of the U.S. Department of Health and Human Services and the Food and Drug Administration.

Grassley also asked the FDA to review a report by a Harvard psychiatrist who had submitted information as part of several lawsuits.

The report found that Glaxo “had to know of Paxil’s suicide risk when it sought FDA approval for the drug,” a statement from the senator said.

The senator has long been critical of both the FDA’s and the pharmaceutical industry’s handling of drug safety information, digging into various cases since Merck & Co Inc’s (MRK.N) withdrawal of its pain drug Vioxx in 2004.

Antidepressants, including Paxil, have stirred particular concern after studies showed an increased risk of suicidal thoughts and actions in children and young adults taking the drugs. The FDA called for new warnings in 2004.

Paxil, known generically as paroxetine hydrochloride, is a type of antidepressant known as a selective serotonin reuptake inhibitor. It is sold in Britain as Seroxat.

FDA spokeswoman Sandy Walsh said the agency would review Grassley’s request and respond to him.

Grassley asked Glaxo in February when it knew of Paxil’s risks. Glaxo has said it provided the FDA a variety of information on suicidal risk in Paxil patients.

“We do feel like we gave Senator Grassley a full and fair response,” spokeswoman Mary Anne Rhyne said on Thursday.

In the report by Harvard’s Joseph Glenmullen, the psychiatrist said Paxil was also shown to increase the risk of suicidality in adults.

Glenmullen, who reviewed internal Glaxo documents made available through various litigation, said the drugmaker knew of the risk since introducing Paxil in the United States in 1989.

“GlaxoSmithKline was aware of the risk, but hid it,” he wrote in the report made public by Grassley.

In 1991, an FDA advisory panel raised concerns about the suicide risks and called for more data, which the company suppressed, Glenmullen told Reuters on Thursday.

“Had the data been actually presented in 1991, we would have had warnings way back then ... and that would have saved a lot of lives,” he said.

In a statement earlier this year and released again on Thursday, Glaxo said Glenmullen’s report was “unscientific and misleading.” (Reporting by Lisa Richwine and Susan Heavey; Editing by Maureen Bavdek and Ted Kerr)

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