Actos Recall In France Forces Closer Look at Side Effects
Actos (pioglitazone), a type-2 diabetes drug, was pulled from the French market by the French Medicines Agency on June 9, 2011. The next day, the German Federal Institute for Drugs and Medical Devices advised physicians not to prescribe Actos to diabetic patients anymore.
On June 15, 2011, the FDA released a drug safety communication concerning the link between Actos and bladder cancer, but so far the agency has not given any indication that it plans an Actos recall. Will future Actos lawsuits change the agency’s mind?
Actos recall based on data from insurance health plan
Actos belongs to a class of drugs called thiazolidinedinoes (TZDs), which work by decreasing insulin resistance in patients with non-insulin-dependent type 2 diabetes. Though it was the tenth best-selling medication in the U.S. in 2008, Actos has been linked with several Actos side effects since it’s release in 1999, including heart failure and fractures.
Suspicion about Actos and bladder cancer started in animal studies. Male rats that received doses of pioglitazone similar to those taken by diabetes patients showed an increased risk of bladder cancer. Later, data from the French National Health Insurance Plan, which included approximately 1.5 million patients with diabetes, found a significant increase in bladder cancer in those patients who took pioglitazone compared to patients taking other diabetes medications. The study also indicated a higher risk for those patients taking higher doses for longer than a year, with men more at risk than women. These results were released in June 2011, which is what caused the French Medicines Agency (Afssaps) to suspend sales of Actos, and later to push for an Actos recall.
In July, manufacturer Takeda agreed to a voluntary recall of the drug in France.
No Actos recall in Germany
After receiving results of the French national insurance study, Germany’s Federal Institute for Drugs and Medical Devices (BfArM) decided to follow suit and suspend sales of the drug.
“BfArM recommends the suspension of approval of pioglitazone (Actos) until further clarification. Doctors should not put new patients on pioglitazone,” the German regulator said. Patients already taking Actos were advised, however, to continue until they could talk with their doctors. So far Germany hasn’t required an Actos recall, but the European Medicines Agency (EMA) is continuing to review the data. The rest of the European Union and Canada are also evaluating Actos side effects like bladder cancer.
FDA releases Actos side effects warning
The FDA’s June warning about Actos side effects—particularly, bladder cancer—came about as a result of a Takeda’s ten-year, observational cohort study. A five-year interim analysis performed with data collected from 1997 through 2008 found that although there was no overall increased risk of bladder cancer when taking pioglitazone, patients who were exposed for more than a year, or to higher doses, did have an increased risk—of 40 percent. The FDA has promised to continue evaluating data as it comes in from the 10-year study.
The first Actos side effects lawsuit targeting bladder cancer was filed in August 2011. According to a British newspaper report, GlaxoSmithKline—which makes Avandia, a TZD diabetes drug similar to Actos—could end up paying as much as $6 billion for personal injury lawsuits. It is much too soon to tell if Actos lawsuits will ever result in similar rewards.