Taking Diabetes Drug Actos Could Lead to a Higher Risk of Developing Bladder Cancer

 

More research is needed but over a period of five years, 138 instances of bladder cancer were reported from patients taking diabetes medications. Over 28 of these patients were taking Actos (pioglitazone). This suggests a "disproportionate risk" in comparison with other anti-diabetics, said study author Dr. Elisabetta Poluzzi of the University of Bologna in Italy."Disproportion is indicative of possible risk," Poluzzi added, "not of an actual risk."

The FDA has said patients should not stop taking Actos unless told to do so by their doctor.

 

Diabetes Drug Avandia Now Under Harsher FDA Restrictions

 

New FDA mandates will make it far more difficult for doctors to prescribe the diabetes drug Avandia. Although the European Medicines Agency has suspended European sales of Avandia-containing drugs, the FDA has NOT banned Avandia in the United States. Regulators say the heart attack risks associated with the drug are ju great a safety concern

 Avandia will be available to new patients only if they cannot achieve [blood sugar] control on other agents and cannot take Actos," FDA commissioner Margaret A. Hamburg, MD, said at a news conference. "Current patients can continue taking Avandia only if they benefit and understand the risks."

Avandia maker GlaxoSmithKline will be required to establish a Risk Evaluation and Mitigation Strategy (REMS) program. Patients, their doctors, and their pharmacists will have to enroll in the program in order to receive, prescribe, or sell Avandia.

In a statement, GlaxoSmithKline says it "continues to believe that Avandia is an important treatment for patients with type 2 diabetes," but that it will work with the FDA and the European Medicines Agency to implement their decisions.

New Adverse Effects from Diabetes Drugs Actos and Avandia

As seen in U.S News and World Report, compared to controls, individuals taking Avandia or Actos had more than double the risk of fractures, with the risk with Actos being slightly higher than with Avandia. Drug-associated fractures were particularly common at the wrist and hip. Both men and women were at risk, and the odds for fracture tended to rise with dose of drug taken.

New Diabetes Drug Could Replace Actos

Takeda Pharmaceutical Co., Japan's biggest drugmaker, sought U.S. approval to sell alogliptin as a once-daily treatment for type-2 diabetes, it said in a statement today. If approved, it will be the Osaka- based company's first new medicine released in the U.S. in more than two years. More...