Healthy Skepticism Library item: 13781

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Publication type: news

Richwine L, Heavey S.
Senator seeks FDA probe of Glaxo's Paxil data
Reuters 2008 Jun 12
http://www.reuters.com/article/healthNews/idUSWAT00965620080612?feedType=RSS&feedName=healthNews&pageNumber=2&virtualBrandChannel=0

Full text:

WASHINGTON (Reuters) – U.S. Sen. Charles Grassley asked U.S. regulators on Thursday to investigate whether drugmaker GlaxoSmithKline Plc 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 Glaxo knew Paxil was associated with a higher risk of suicidal behavior in adolescents as far back as 1998.

“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 has submitted information as part of several lawsuits. The report found 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 and Co Inc’s 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 and 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,” company spokeswoman Mary Anne Rhyne told Reuters on Thursday.

(Reporting by Lisa Richwine and Susan Heavey; Editing by Dave Zimmerman and Maureen Bavdek)