The FDA approved Actos (pioglitazone) in 1999 for the treatment of type II diabetes, but since then, the drug has been linked with increasing the risk of bladder cancer. In June 2011, the FDA warned physicians and patients that taking the medication for longer than a year could increase risk. Studies suggested that patients taking the medication long-term had a 40 percent increased risk of cancer. In July 2011, France implemented an Actos recall, pulling the drug from the shelves.
Now, the Indian Ministry of Health has announced it is also banning Actos from the market. As reported in The Times of India, the decision comes in the wake of a strong stand by the government on suspending marketing of all drugs prohibited for sale in other countries like the U.S., the U.K, and Australia.
History of Safety Concerns
Along with painkiller Analgin and anti-depressant Deanxit, Actos has been banned under Section 26A of the Drugs and Cosmetics Act, 1940, effective immediately within India. Actos remains for sale in other major markets, including the U.S. and the U.K.
In August 2007, the FDA released a safety communication alerting physicians and patients that Actos could cause or exacerbate heart failure, particularly in certain populations. A black box warning was added to the product label at the time.
It was not until September 2010, however, that the FDA announced an ongoing safety review on Actos concerning its potential link to bladder cancer. The agency stated it was reviewing the five-year results of an ongoing 10-year epidemiologic study on Actos and the disease.
Lack of Warnings Prompts Lawsuits
In April 2011, the American Diabetes Association published a report showing a clear association between Actos and bladder cancer. Researchers had analyzed adverse event reports concerning the drug made between 2004 and 2009.
In June 2011, the European Medicines Agency issued a press release concerning findings from the French Medicines Agency, and its decision to suspend Actos from the market. Germany followed suit by telling doctors to write no new Actos prescriptions.
In August 2011, after the FDA had warned that patients taking Actos for more than 12 months were at an increased risk of bladder cancer, manufacturer Takeda implemented label changes to warn patients about the risk. Between 1999 and 2011, however, no such warnings existed, prompting a number of lawsuits.
Studies Confirm Actos-Bladder Cancer Link
Following the 2011 FDA warning, more studies have linked Actos use to bladder cancer. In May 2012, the British Medical Journal reported that the cancer risk doubled in patients taking Actos for at least two years. In July 2012, the Canadian Medical Association Journal (CMAJ) published a meta-analysis showing that Actos was linked to an overall 22 percent increased risk of bladder cancer.
The U.S. Judicial Panel on Multidistrict Litigation formed the Actos MDL in the Western District of Louisiana in December 2011. The first bellwether trials are currently scheduled for January 2014. Claims in Illinois have also been consolidated in state court.