The Justice Department of the United States announced that GlaxoSmithKline LLC has agreed to pay a $3 Billion fine as well as plead guilty to promoting two of their drugs for unapproved uses and failing to disclose safety information with a third drug.
In a practice known as off-label marketing, prosecutors stated that GlaxoSmithKline promoted the drug Paxil for treating children with depression from April 1998 to August 2003 despite Paxil being approved only for people over the age of 18.
The company also promoted Wellbutrin for weight loss, sexual dysfunction, substance addictions and attention deficit disorder from the period of January 1999 to December 2003. However, Wellbutrin is only approved for treatment of major depressive disorder.
The Justice Department further reported that the corporation did not report safety issues with the diabetes drug, Avandia, between 2001 and 2007 after problems were discovered in certain post-marketing studies and two studies on the cardiovascular safety of the drug.
The fine will be the largest to be paid by any drug company. The guilty plea and sentence must be approved by the federal court in Massachusetts. Deputy Attorney General James M. Cole stated the company will be monitored by government officials for the next five years to ensure compliance.
Not knowing all of the side effects of a drug can lead to other health problems. If you or a loved one knows someone who has dealt with medication issues, call Spiros Law, P.C. at (815) 929-9292 to explore your legal rights.
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