British drugmaker GlaxoSmithKline recently agreed to pay $3 billion to settle criminal and civil allegations centering around its promotion of dangerous pharmaceuticals for off-label purposes. Off-label marketing is a common practice among major drugmakers and typically involves the promotion of a drug to treat ailments without adequate studies into whether the drug is safe for this unapproved use.
Authorities allege that GlaxoSmithKline went beyond promoting drugs without adequate clinical safety data and actually fabricated research to promote some of its pharmaceuticals. In the case of the antidepressant drug Paxil, authorities say that GSK helped author and publish a misleading article in a medical journal which indicated that Paxil was effective in pediatric patients. In reality, the drug increases the suicide risk in patients under 24 and has not been shown to be effective in young patients.
The drug’s warning label now reads, “Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these condition.”
It is unclear whether GSK’s off-label marketing of Paxil lead to any child deaths. Serious side effects of Paxil include abnormal bleeding, seizure, breathing issues, blurred vision and fainting. Some patients also reported hallucinating and chest pain after taking the drug.
Source: The New York Times, “Glaxo Agrees to Pay $3 Billion in Fraud Settlement,” Katie Thomas and Michael S. Schmidt, July 2, 2012