The type 2 diabetes drug Actos (pioglitazone) carries an even greater risk for bladder cancer and heart problems than previously noted during a Food and Drug Administration (FDA) review, according to a new study published in the British Medical Journal.
Actos is in a class of type 2 diabetes medications known as thiazolidinediones, or TZDs. Another member in this class is Avandia (rosiglitazone).
The safety of both drugs has come under scrutiny in recent years. In 2010, the FDA severely restricted the use of Avandia after the drug was linked to fatal heart attacks. Actos was considered a safer choice until studies began to link the drug to bladder cancer. Those studies resulted in an FDA safety announcement and updated labeling to warn of the bladder cancer risk.
The most recent study included 115,727 type 2 diabetes patients who were treated with oral hypoglycemic agents between January 1988 and December 2009. Sixty-seven percent of the patients received metformin alone, 30 percent took sulfonylurea only, and .5 percent took a TZD. Duration of TZD use was 2.2 yeas with Actos and 2.3 years with Avandia.
Previous studies put the risk of bladder cancer in patients who used Actos for at least 12 months at 40 percent. The latest study puts the risk much higher – at 83 percent. Patients who took Actos for two years or longer, and those who used the drug at higher dosages, were at even greater risk.
Since Avandia was restricted in 2010, prescriptions for Actos increased. It was thought to be a safer alternative, but new studies show it may soon follow in Avandia’s footsteps. The new study also showed that the risk for heart attack, heart failure or death was just as great for patients taking Actos as for those taking Avandia.
Source: Cardiovascular Business