South Carolina Lawyer Blog
After a five-year study, the U.S. Food and Drug Administration (FDA) recently announced that patients who took certain medications for diabetes may now have a much greater risk of bladder cancer.
According to the FDA safety announcement, those who took the prescription drug pioglitazone, sold under the brand name Actos, may be at risk. The drug is also a part of diabetes medications sold under the names Actoplus Met, Actoplus Met XR, and Duetact. These prescriptions are used most often in the treatment and control of type 2 diabetes in adults.
Also according to the FDA, 2.3 million patients filled prescriptions for medications containing the drug pioglitazone in the first 10 months of 2010. The FDA safety announcement is the result of both the five-year data review by the FDA and a recent study in France, which showed that exposure to pioglitazone increases the risk of bladder cancer over time.
No studies have yet to show a direct link between the drug and bladder cancer, but experts do agree that studies have shown that use of the drug over an extended period of time puts patients at risk. According to the FDA review, patients exposed for a period of 12 months or more had a 40 percent increase in risk of bladder cancer. The French study showed that an increased risk was particularly associated with male patients.
The FDA has said that it will continue to monitor data from patients prescribed diabetes drugs like Actos. France has suspended use of pioglitazone, and Germany has recommended its physicians not prescribe the drug for use in new diabetes patients.
People who are currently taking or have taken diabetes medications containing the drug should be aware of the increased bladder cancer risk, as well as potential symptoms of bladder cancer, according to the FDA. Problems such as pain while urinating, an urgent need to urinate, pain in the lower back and abdomen, or appearance of blood or a red color in urine may indicate the presence of bladder cancer.
The FDA also recommends that patients talk to their doctors about any problems or concerns about diabetes prescription drugs.