Dangerous diabetes drug following same path as Darvon, Darvocet

Another drug appears to be going down a similar path as the painkiller propoxyphene, known by the brand names Darvocet and Darvon, in the annals of banned drugs. Last week, German and French drug regulators banned the type 2 diabetes drug piogliazone (Actos) after reviewing data from a French study that suggested the drug put users at greater risk for bladder cancer.

However, the Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) and Japanese drug authorities, opted to gather more data before deciding the fate of the drug.

The FDA officially banned the popular prescription painkiller propoxyphene late last year after studies showed the drug put users at risk for deadly heart rhythm abnormalities. The agency’s decision followed similar bans from drug regulators in the United Kingdom and the European nations. The FDA has caught flack from citizen watchdog groups for dragging its feet on the ban.

The FDA also was late to heavily restrict another type 2 diabetes drug, Avandia, after studies showed the drug put users at grave risk for heart attacks.

In September 2010, the FDA issued a drug safety communication stating that it was reviewing data from an on-going, 10-year epidemiology study designed to evaluate whether Actos was associated with an increased risk for bladder cancer. The agency at that time said it had not concluded that Actos increases the risk of bladder cancer, but that it would continue to review data and update the public when it has more information.

Med Page Today