Actos under Investigation in Texas

Austin, TXAlthough Actos side effects have not been deemed serious enough to put strict limits on how the medication is used, Actos still reportedly has some severe side effects. Those side effects reportedly include a risk of Actos heart failure. Now, the maker of Actos diabetes medication has been asked to send in documents related to an investigation of the medication, although details of that investigation have not been made public.

According to a report by The Wall Street Journal (02/22/11), Texas Attorney General Greg Abbott requested that Takeda Pharmaceutical Co. and Eli Lilly & Co. send in documents related to Actos. Eli Lilly & Co. reportedly received the request in December 2010. Although Eli Lilly said it is cooperating with the attorney general's office, the company had no comment about the investigation.

Takeda Pharmaceutical also said it was cooperating but had no further comment. A spokesman for the Texas attorney general confirmed that requests for documentation were made but would not provide any details about the investigation.

Takeda Pharmaceuticals became the sole marketer of Actos in 2006. Prior to that, Takeda and Eli Lilly shared marketing of the drug from 1999, when the drug was first approved, until Lilly's rights to the drug expired.

Recently, the US Food and Drug Administration (FDA) put Actos on a list of drugs targeted for potential safety concerns. According to a 01/31/11 report by the FDA, Actos (known generically as pioglitazone) is being evaluated for a risk of rhabdomyolysis, a condition in which the patient's muscle fibers are broken down and the contents are released into the bloodstream. The condition can result in kidney damage.

"FDA is continuing to evaluate this issue to determine the need for any regulatory action," the report states. Although Actos is on the list for potential safety concerns, that does not mean that Actos has been shown to cause rhabdomyolysis, just that it is linked to the condition.

In addition to concerns about rhabdomyolysis, the FDA is evaluating Actos for a link to bladder cancer.

Actos has been linked to a risk of congestive heart failure and serious liver problems. Despite the risks associated with Actos, it has not been subjected to the same strict limitations as those recently placed on Avandia regarding that medication's use.