FDA & EMA: Regulatory Bodies and Their Stand Vs. Bladder Cancer Risk



The European Medicines Agency (EMA) seemed to tilt toward the direction taken by the Food and Drugs Administration (FDA) regarding Actos (pioglitazone) bladder cancer risk.

With the move of France to suspend sales of Actos and Germany to restrict prescription of the type 2 diabetes drug severely, the watching world expected the agency to recommend an Actos recall.

In October 2011, EMA, however, announced that after the reviews of available data, no Actos recall would take place. EMA believed that Actos is still an effective type 2 diabetes treatment.

Taking into consideration the Actos bladder cancer risk, EMA suggested physicians to prescribe Actos only when other treatments for type 2 diabetes failed. It also prompted physicians to monitor patients carefully for any signs of a growing bladder tumor.

Prior to the June 15 confirmation from the FDA that Actos could indeed cause bladder cancer, France has already published results of its own study regarding the link between Actos and bladder cancer. While the findings convinced France and Germany to take tough regulatory measures, EMA and FDA thought otherwise.

With three studies screaming Actos bladder cancer link, the FDA merited Actos a black-boxed warning for bladder cancer. It required Takeda to reflect the new development, and when Takeda did a month later, Actos was once again available for prescription as if there were no bladder cancer link, no heart failure, no lawsuits, and no deaths. The diabetes drug is still effective to lower blood sugar level, that’s what matters.

EMA and FDA upheld a wait-and-see policy while at least 1,140 cases of adverse reaction to Actos have been reported in the United Kingdom.

There were at least 2.3 million Americans who were prescribed Actos in the first nine months of 2010. In the United Kingdom, nearly 233 thousand diabetic patients were prescribed Actos for the same year.

The first of the three studies published in 2011 establishing the link of Actos to bladder cancer was conducted by the American Diabetes Association (ADA). ADA reviewed and analyzed reports on FDA’s Adverse Event Reporting System (AERS) and confirmed the obvious: Actos can cause bladder cancer.

In July 2011, the first batch of Actos bladder cancer lawsuits was filed in the U.S. Plaintiffs alleged Takeda of negligence, fraud, and deceit.

In December 2011, it was decided that all Actos bladder cancer claims would be consolidated for multidistrict litigation (MDL). One judge will be assigned to handle the cases for pretrial proceedings in one federal court. Currently, around 170 charges are consolidated before Judge Rebecca Doherty of the Western District of Louisiana. The first hearing is scheduled on March 22.

Actos, approved by FDA in 1999, is linked to a fleet of side effects from the most common like headache and cold and flu-like symptoms, to the most deadly, congestive heart failure, macular edema, bladder cancer, and liver and kidney damage.

Actos became a hit as it effectively carries out its selling point: lower blood sugar. With Avandia’s highly publicized 43 percent increased risk for heart failure, Actos gained the trust of the medical community and consumers. It enjoyed burgeoning sales after the 2007 publication of studies linking Avandia to heart failure, and in 2008 signaled its ascent to top: Actos from that year on has become the top-selling diabetes drug worldwide.



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