India Bans Actos Sales Based on Bladder Cancer Risks

Following in the footsteps of Germany and France, both of which mandated an Actos recall due to bladder cancer concerns, the Indian Ministry of Health and Welfare announced it was banning the controversial diabetes drug pioglitazone. As reported in The Times of India, the announcement came as a surprise to many in the medical industry; however, the government stands behind its commitment to prohibiting all drugs that have been suspended or recalled in other international markets.

The decision to ban pioglitazone amid evidence of increased Actos bladder cancer risk will take a dent out of revenues for Indian pharmaceutical companies that sell the drug’s generic counterparts. Companies like Sun Pharma, USV, Abbott and Ranbaxy are up in arms, citing the need for more conclusive reviews regarding Actos and bladder cancer.

Indian officials also made reference to other safety concerns regarding Actos and heart failure – a potentially fatal side effect that garnered a black box label warning.

Studies point to Actos bladder cancer risk

Approved in July 1999 for the treatment of type 2 diabetes, Actos is manufactured by Takeda Pharmaceuticals. In the United States, the company is presently embroiled in litigation over life-threatening side effects alleged by plaintiffs who argue that Actos exposure caused their bladder cancer. While the insulin sensitizing medication may help some patients manage their blood sugar levels, Actos bladder cancer concerns prompt many to question whether the benefits outweigh the risks.

Post-marketing reports and clinical findings have demonstrated a causal link between long-term Actos use and bladder cancer. On August 4, 2011, the FDA published a safety communication announcing its approval of a bladder cancer warning on all medications containing pioglitazone. The Actos cancer warning states: “the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.”

An August 2012 study published in the Journal of the National Cancer Institute revealed that patients who take Actos may have triple the risk of developing bladder cancer when taken for more than five years. Another study in the British Medical Journal found that Actos use for two years may double bladder cancer risks.

No plans for Actos recall in the United States

Despite medical and anecdotal evidence pointing to Actos bladder cancer risk, the FDA continues to investigate the long-term safety of the drug and has made no mention of a suspension of sales. It remains to be seen whether the Indian Actos recall will be permanent – or just a temporary ban on sales as drug makers are taking steps to reverse the ministry’s actions, leading many to wonder if companies are putting profits over consumer safety.

1,500+ lawsuits pending against Takeda

Legal analysts speculate that Takeda Pharmaceuticals could soon face as many as 10,000 product liability claims arguing that the company is liable for designing a defective product and failing to adequately warn of Actos side effects.

Actos lawsuits are in various stages throughout the nation, with mass torts proceeding on the state level in Illinois and California, and multidistrict litigation established in Louisiana federal court. The Actos Products Liability MDL No. 2299 should be ready for bellwether trials in January of 2014.