Large Study On Actos Side Effects Results In First Safety Alert
In September of 2010 the FDA issued the following statement “FDA notified healthcare professionals and patients that the Agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study. At this time, FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information.” The FDA’s recommendation to healthcare providers at this point was to continue to follow the recommendations in the drug label when prescribing Actos. It was not until close to a year later that a change to the warning label was made.
FDA Issues A Second Update On Actos Bladder Cancer
On June 15, 2011 the FDA issued an update on it’s investigation of the association between Actos and bladder cancer. This time the FDA issued a warning stating “(u)se of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.” They also recommended that healthcare professionals should not use pioglitazone in patients with active bladder cancer, and use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.
FDA Finally Adds Actos Bladder Cancer To Label
The FDA issued another warning in August 2011 regarding Actos side effects. The FDA updated the labeling of this medication, to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.
Needless to say with all these updates and warning information, if you or your loved one have been prescribed Actos, please speak to your physician regarding the potential risk of bladder cancer due to taking this medication.[related_posts limit=”5″]