Might Numerous Actos FDA Warnings Lead to a Recall?

On September 17, 2010, the FDA released a drug safety communication concerning the diabetes drug Actos. Specifically, they announced that they were reviewing data from an ongoing, ten-year epidemiological study to evaluate whether Actos (pioglitazone) might be associated with bladder cancer. Nine months later, on June 15, 2011, the agency released an FDA Actos warning stating that, “use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.”

About the same time, France announced an Actos recall, and Germany recommended no new prescriptions for the drug, leading many to wonder whether or not an FDA Actos recall may be in the works.

Actos FDA Warning Slow in Coming

Before the FDA Actos warning, scientific studies indicated a risk of bladder cancer in patients taking Actos as early as 2005. Before that, animal studies indicated a risk, but an Actos FDA warning was slow in coming as the agency wanted to be absolutely sure before releasing information that could upset diabetes treatment.

Used to help control blood sugar, Actos gained FDA approval in 1999, and since then has experienced a steady increase in warning requirements. In 2007, the agency issued an FDA Actos warning concerning heart failure, which was found to occur more often in people taking Actos. Other Actos FDA warnings included the risk of limb fractures, particularly in postmenopausal women. The Actos FDA warning on bladder cancer wasn’t released until 2011, however, when the agency felt it had finally received enough data to make the call.

The Possibility of an FDA Actos Recall

As to whether or not the agency might implement an FDA Actos recall, it’s still too early to tell. In the June 2011 FDA Actos warning, the agency stated that they would “continue to evaluate date from the ongoing ten-year epidemiological study.”

They also promised to review the epidemiological study conducted in France, which indicated a higher risk of bladder cancer in those taking Actos, and was the catalyst for the French Actos recall and the German recommendation for no new prescriptions. Though the agency plans to communicate any further conclusions, those aren’t expected to be released until 2012.

An Actos Lawyer May be Able to Help

Even without an FDA Actos recall, those injured by Actos are eligible to file a claim to recover medical expenses, pain, and suffering. If you or a loved one has experienced an injury as a result of Actos, you may be eligible for compensation in an Actos lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.