Magazine article Clinical Psychiatry News

GSK to Pay $3 Billion to Settle Drug Promotion Charges

Magazine article Clinical Psychiatry News

GSK to Pay $3 Billion to Settle Drug Promotion Charges

Article excerpt

GlaxoSmithKline has agreed to pay $3 billion to the federal government and plead guilty to charges of illegally promoting two antidepressants and withholding key safety information about the diabetes drug Avandia.

As part of the settlement, the pharmaceutical company is admitting to promoting the drugs Paxil and Wellbutrin for off-label uses and failing to report safety data about Avandia to the Food and Drug Administration.

In the case of Paxil, the government charges that, from 1998 to 2003, GSK sponsored dinner and spa programs to encourage physicians to prescribe the drug for children and adolescents, even though it was not approved for pediatric use. The government also alleges that the company prepared and published a misleading medical journal article providing false information about the efficacy of Paxil in patients under age 18. The government also charged that GSK paid physicians to promote off-label uses of Wellbutrin ranging from weight loss to the treatment of sexual dysfunction.

GSK also withheld safety data about the diabetes drug Avandia, including data from postmarketing studies and two other studies conducted in response to concerns about the cardiovascular side effects of the drug, according to the U. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.