On May 23, 2007, the Food and Drug Administration asked Takeda Pharmaceuticals to add a “black-box” warning to its diabetes drug Actos after it was linked to an increased risk of congestive heart failure. The black-box warning is the strongest kind issued by the FDA.

Actos, one of the TZDs
Actos (pioglitazone) is among a class of drugs known as thiazolidinediones (TZDs), which are designed to treat patients with type 2 diabetes. Studies have linked TZDs to an increased risk of liver toxicity, heart attacks and heart-related deaths.

Rezulin, the first TZD sold in the United States, was withdrawn in 2000 after it was linked to an increased risk of liver toxicity. The only other TZD still on sale in the U.S., Avandia, was recently linked to a 64% increased risk of heart-related death and a 43% increased risk of heart attack.

A study conducted by the FDA in 2002 suggested that TZDs could cause fluid retention, which can lead to or aggravate congestive heart failure. Since Actos was approved in 1999, the FDA has received reports of at least 493 patients who suffered congestive heart failure after using Actos. Of this group, 388 needed to be hospitalized because of Actos side effects.

Liver injury and hepatitis
The FDA also warns about the risk of liver injury and hepatitis in patients taking Actos. The agency has received reports of patients whose liver enzyme levels were three times the norm. In some cases, these patients experienced liver failure. A 2002 study in the Annals of Internal Medicine also reported a link between Actos and liver injuries.

If you or a loved one have suffered Actos side effects such as heart problems or liver injury, you may wish to consider filing a lawsuit. To speak with an Actos attorney, contact the law office of Sam Levine by calling toll-free (888) 404-LAWYER or by filling out our contact form.