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Actos Bladder Cancer and Heart Disease FAQ

What is Actos?

Actos, known generically as pioglitazone hydrochloride, is in a class of drugs known as thiazolidinediones. It is used to treat type 2 diabetes and was initially approved by the FDA in 1999.

What are Actos side effects?

Actos has been linked to side effects including rhabdomyolysis, heart failure, weight gain, fractures, edema and possibly bladder cancer.

What is rhabdomyolysis?

Rhabdomyolysis is a condition in which the patient's muscle fibers deteriorate and enter the bloodstream. It can result in kidney failure.

Is there an Actos class action lawsuit?

There are currently no Actos class action lawsuits. Because injuries sustained as a result of medications would vary for each patient, it is likely that no class action lawsuit would exist (class action lawsuits require commonality of injury). This does not mean there may not be Actos lawsuits filed.

What does the FDA say about Actos side effects?

The FDA currently has Actos on a list of drugs to watch for the possible link to rhabdomyolysis. Although the FDA has not found a causal link between Actos and rhabdomyolysis, there is concern about a potential connection. The FDA is evaluating the issue to determine if regulatory action should be taken.

The FDA is also evaluating Actos for a possible link to bladder cancer following preliminary results of a long-term study that found patients with the longest exposure to Actos and the highest cumulative dose of the drug had an increased incidence of bladder cancer. The FDA, however, has not concluded that Actos causes bladder cancer.

The Actos warning label currently carries a black box warning, alerting patients to the risk of heart failure.

What do studies say about Actos side effects?

A study published in the British Medical Journal (08/19/09) found that although patients who took Actos had a lesser risk of heart failure or dying than patients who took Avandia, there was no significant difference in the risk of heart attacks.

A 2005 study called PROactive Study and published in The Lancet found an increased risk of weight gain, non-serious hypoglycemia and heart failure in patients who took Actos.

Why is there concern about Actos now?

Any potential damage linked to Actos has been overshadowed by concern about rival drug Avandia. Now that the FDA has severely restricted Avandia use and halted the TIDE trial—designed to compare the safety of Avandia with the safety of Actos—the focus has shifted to Actos.
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Last updated on Mar-18-11

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