FDA Warnings, Overseas Bans End the Use of Diabetes Drug, Actos

Manufacturers of the diabetes drug Actos have spent much of 2011 facing questions about the ban of the drug in some European countries and FDA warnings involving its link to bladder cancer. The manufacturers, Takeda and Eli Lilly, have also been served with multiple lawsuits stemming to Actos’ link to bladder cancer.

In June of this year, CBS News reported that Actos had been banned in Germany and France.  According to the news source, the French Medicines Agency used a government-funded study to find that Actos increased the risk of bladder cancer. According to the report, French doctors were advised to not prescribe the diabetes drug and patients currently taking the drug were advised to consult their doctors.

Following the results of the government-funded report in France, German health officials went on to ban the drug as well. That French study followed diabetic patients from 2006 to 2009.

A little more than a week after reports of the European ban on Actos were released, the United States Food and Drug Administration (FDA) released a safety announcement focused on the diabetes drug. Within the announcement, the FDA advised healthcare professionals to keep from prescribing Actos to patients who have active bladder cancer.

The FDA also said to use caution when prescribing Actos to patients “with a prior history of bladder cancer.” The FDA concluded their safety announcement by explaining they will continue to “evaluate data from the ongoing ten-year epidemiological study,” as well as “conduct a comprehensive review of the results from the French study.”

With the increasingly publicized link between Actos and bladder cancer throughout the summer, Takeda and Eli Lilly have subsequently faced several lawsuits in the latter half of this year. One of these cases involves a class action lawsuit that was filed in the U.S. District Court of the Eastern District of Louisiana. The lawsuits were filed by two former users of Actos who later developed bladder cancer.

Filed on September 16, the lawsuit states that Takeda and Eli Lilly both had high financial incentive to conceal any and all dangers that were associated with Actos, including the alleged link to bladder cancer. The class action suit is seeking medical monitoring, damages, and other compensation for individuals who have taken Actos and developed bladder cancer since the drug’s introduction in 1999.

A U.S. Judicial Panel centered on Multidistrict Litigation will be making a decision on whether this class action Actos lawsuit will be compacted to one judge for all proceedings.

References:

About Lawsuits Staff. (October 12, 2011) “Actos Class Action Lawsuit Filed Over Bladder Cancer Risk.” Retrieved on October 19, 2011 from About Lawsuits.

Jaslow, Ryan. (June 10, 2011) “Actos banned in Europe after diabetes drug tied to cancer.” Retrieved on October 19, 2011 from CBS News.

U.S. Food and Drug Administration Safety Announcement (June 6, 2011) “FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer.” Retrieved on October 19, 2011 from the FDA.