What’s In the Recent FDA Actos Warning?

On June 15, 2011, the FDA issued an Actos warning concerning Actos bladder cancer. What did the warning say, and what should patients and healthcare professionals do to ensure safety?

FDA Actos Warning

The FDA issued an earlier Actos cancer warning in September of 2010. At that time, they announced that they were reviewing data from an ongoing, ten-year epidemiological study designed to determine whether or not Actos might increase the risk of bladder cancer. The agency stated that they were looking into the issue because, “Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.”

At that time, the FDA already had information that seemed to indicate that patients with the longest exposure and highest dose of Actos were at an increased risk of bladder cancer. In their September Actos warning, however, they refrained from concluding that Actos increased the risk of this disease. It wasn’t until nine months later that they issued another warning saying that that use of Actos for more than a year may be associated with an increased risk of bladder cancer.

FDA Actos Cancer Warning Alerts Physicians to the Risk

At the time of the FDA’s Actos cancer warning, France had also completed a large epidemiological study that concurred with the FDA’s review—that Actos was associated with an increased risk of bladder cancer. France implemented an Actos recall as a result. The FDA did not implement a recall, but instead issued the following Actos warnings, suggesting that healthcare professionals should:

• Not use actos in patients with active bladder cancer.
• Use Actos with caution in patients with a history of bladder cancer.

The agency also recommended physicians counsel patients about the symptoms of bladder cancer, and encourage patients to read the medication guide.

Other FDA Actos Warnings

Before this latest FDA Actos warning, the agency issued other Actos warnings. The most serious was a 2007 Actos warning about the increased risk of congestive heart failure, particularly for those with a history of cardiovascular disease. At that time, the agency required manufacturer Takeda to place a black-box Actos warning on the label, to increase visibility and be sure both doctors and patients were aware. Takeda and the FDA also issued an Actos warning in 2007 concerning reports of limb fractures in women taking Actos.

The Actos cancer warning has not yet reached the black-box stage, but additional studies may change that, depending on the results.

An Actos Lawyer May be Able to Help

If you or a loved one has suffered from an injury caused by 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.