Drug maker GlaxoSmithKline (NYSE:GSK, Stock Forum) has agreed to pay $3 billion in criminal and civil fines and plead guilty to misdemeanour criminal charges related to the sale and marketing of its antidepressants Paxil and Wellbutrin and the diabetes drug Avandia in the largest health care fraud settlement in U.S. history.
According to published reports, the British pharmaceutical giant has admitted to misbranding the antidepressants Paxil and Wellbutrin and marketing them for uses not approved by the U.S. Food and Drug Administration (FDA), including the treatment of children for depression and the treatment of ailments such as obesity, anxiety, addiction and ADHD.
In some cases, the company did so despite warnings from the FDA, such as an increased risk of suicide for children under 18 taking antidepressants.
The company also admitted in the settlement that it did not provide the FDA with safety information that indicated its diabetes drug Avandia might cause heart problems. The drug was eventually pulled off the shelves in Europe and its sale restricted in the U.S.