Takeda has been ordered to pay $2.4bn to settle hundreds of law suits in the US that allege its diabetes drug Actos increases the risk of certain cancers.
Actos (pioglitazone) is licensed to help patients with type II diabetes reduce their sugar levels and has been on the market for more than 15 years.
In 2011 the FDA slapped a Black Box safety warning on the drug indicating that it can increase the risk of bladder cancer.
Since then thousands of lawsuits have been filed against Takeda after new studies came to light showing a significant increase of risk for those patients taking Actos and being diagnosed with bladder cancer.
Sales of Actos peaked in 2011 at $4.5bn, but has since been slowly declining as new drugs have taken some market share combined with fresh concerns over its safety profile.
Actos has generated more than $16bn in sales since its 1999 release, according to court filings, but now also faces generic competition from India’s Ranbaxy Laboratories.
Lilly, who was Takeda’s US partner in selling and marketing the drug over seven years from 1999, have previously contended Takeda agreed to cover all legal costs stemming from its US sales, and is therefore not named in this case.
As in common in such settlements, the Japanese firm has not admitted liability and believes the litigation is “without merit”.
It will still, however, pay around $2.4bn into a settlement fund for the plaintiffs, and also take a $2.7bn charge against earnings it made in the fourth quarter of 2014. This works out at around $300,000 being paid out per case.
The company said it would not be pulling the medicine from other markets as a result of this week’s outcome.
The $2.4bn will be one of the largest pay outs in US history for a drug’s safety, with the largest being the 2007 settlement from Merck & Co, which paid $4.85bn to settle about 30,000 lawsuits over its withdrawn painkiller Vioxx (rofecoxib).