UPDATE 3-US senator seeks FDA probe of Glaxo's Paxil data
ju4 wa4i dia4n zo1ng he2 ba4o da4o :\n  (Adds scientist comment, report details)\nWASHINGTON, June 12 (Reuters) - U.S. Sen. Charles Grassley\nasked regulators on Thursday to investigate whether drugmaker\nGlaxoSmithKline Plc <GSK.L><GSK.N> withheld data about a risk\nof suicide linked to its anxiety disorder drug Paxil.\nGrassley, a Republican from Iowa, said in a letter that a\nBritish regulatory agency had found that Glaxo knew as far back\nas 1998 that Paxil was associated with a higher risk of\nsuicidal behavior in adolescents.\n"I would like you to take a look at the information that\nagency gathered and determine if the company has withheld\nsafety information here as well," Grassley wrote in the letter\nto the heads of the U.S. Department of Health and Human\nServices and the Food and Drug Administration.\nGrassley also asked the FDA to review a report by a Harvard\npsychiatrist who had submitted information as part of several\nlawsuits.\nThe report found that Glaxo "had to know of Paxil's suicide\nrisk when it sought FDA approval for the drug," a statement\nfrom the senator said.\nThe senator has long been critical of both the FDA's and\nthe pharmaceutical industry's handling of drug safety\ninformation, digging into various cases since Merck & Co Inc's\n<MRK.N> withdrawal of its pain drug Vioxx in 2004.\nAntidepressants, including Paxil, have stirred particular\nconcern after studies showed an increased risk of suicidal\nthoughts and actions in children and young adults taking the\ndrugs. The FDA called for new warnings in 2004.\nPaxil, known generically as paroxetine hydrochloride, is a\ntype of antidepressant known as a selective serotonin reuptake\ninhibitor. It is sold in Britain as Seroxat.\nFDA spokeswoman Sandy Walsh said the agency would review\nGrassley's request and respond to him.\nGrassley asked Glaxo in February when it knew of Paxil's\nrisks. Glaxo has said it provided the FDA a variety of\ninformation on suicidal risk in Paxil patients.\n"We do feel like we gave Senator Grassley a full and fair\nresponse," spokeswoman Mary Anne Rhyne said on Thursday.\nIn the report by Harvard's Joseph Glenmullen, the\npsychiatrist said Paxil was also shown to increase the risk of\nsuicidality in adults.\nGlenmullen, who reviewed internal Glaxo documents made\navailable through various litigation, said the drugmaker knew\nof the risk since introducing Paxil in the United States in\n"GlaxoSmithKline was aware of the risk, but hid it," he\nwrote in the report made public by Grassley.\nIn 1991, an FDA advisory panel raised concerns about the\nsuicide risks and called for more data, which the company\nsuppressed, Glenmullen told Reuters on Thursday.\n"Had the data been actually presented in 1991, we would\nhave had warnings way back then ... and that would have saved a\nlot of lives," he said.\nIn a statement earlier this year and released again on\nThursday, Glaxo said Glenmullen's report was "unscientific and\nmisleading."\n(Reporting by Lisa Richwine and Susan Heavey; Editing by\nMaureen Bavdek and Ted Kerr)\n((lisa.richwine@thomsonreuters.com; 1 202 310-5691; Reuters\nMessaging: lisa.richwine.reuters.com@reuters.net))\nKeywords: CONGRESS/GLAXO