FDA Approves Final Warning Language for Actos

According to a Drug Safety Communication issued last week, the U.S. Food and Drug Administration announced it has approved the final language for the new Actos label. The drug’s label now includes warning language regarding the increased risk for bladder cancer in patients taking the medication for more than a year. The updated label also recommends that doctors not prescribe the drug to patients with active bladder cancer and directs healthcare provider remain cautious when using Actos to treat patients with a history of bladder cancer.

The FDA has advised patients who are already taking Actos to immediately notify their doctor should they see blood in their urine, experience urgent needs to urinate, pain while urinating or pain in the back or lower abdomen, all of which could be early signs of bladder cancer.

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