A US judge on Thursday approved an agreement by British drugmaker GlaxoSmithKline to pay US$3 billion for criminal and civil violations involving 10 drugs, the largest health care fraud settlement in US history.
The amount of money involved led US District Judge Rya Zobel to remark in court that she was having trouble keeping track of the numbers.
GlaxoSmithKline pleaded guilty to promoting the popular antidepressants Paxil and Wellbutrin for unapproved uses.
Government officials said in the original complaint that the company promoted Paxil as safe for children and adolescents, even though the US Food and Drug Administration had not approved it for those patients and the pharmaceutical giant’s clinical trials had raised concerns about an increased risk of suicide.
Prosecutors had charged that the drugmaker promoted Wellbutrin for unapproved uses that included treating attention deficit disorder, bipolar disorder, obesity, sexual dysfunction and anxiety when it was not shown to be safe and effective for those uses.
The company also admitted that it had failed to report to the government some of the safety issues with Avandia.
In 2010, the diabetes drug was restricted in the US and prohibited in Europe after it was found to sharply increase the risks of heart attacks and congestive heart failure.
When the US government announced the settlement on Monday, US Deputy Attorney General James Cole called it a historic ruling, saying it sent a clear warning to any company that chooses to break the law.