The US FDA has revised its existing safety warning regarding pioglitazone.

Dear AACE Member,

Following our news on Actos (pioglitazone) on 6-13-11.

Today, The United States Food and Drug Administration (FDA) has revised its existing safety warning regarding pioglitazone for the treatment of diabetes. The FDA announcement follows the announcement by the French Regulatory authorities that they suspended marketing of pioglitazone and the Germen recommended against new initiations of pioglitazone, owing to a recent study indicating a small increase in the risk of urinary bladder cancer in patients takingpioglitazone.

The FDA announced that use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. Therefore it revised its existing safety warning regarding pioglitazone to note that those patients on the highest doses and for the longest period of time did show some increased rate of malignancies in bladder cancer. In some data sets, patients taking pioglitazone for more than twelve months showed a 40% increase in the risk of bladder cancer. However, the FDA review of the five-year interim results of an ongoing, ten-year epidemiological study (described in FDA's September 2010 ongoing safety review ) showed that there was no overall increased risk of bladder cancer with pioglitazone.

Consequently, the FDA recommends that no patient with urinary tract or bladder cancer, or a prior history of such a malignancy, be started on pioglitazone or maintained on it without thorough evaluation and consideration by the treating physician. Continuation of pioglitazone therapy in patients without bladder cancer is a matter for individual consideration by patients and physicians.

Therapeutic decisions regarding antidiabetic therapies, as with all other therapeutic decisions, should be the result of physician – patient consultation and consideration. In no instance should patients unilaterally stop or reduce pioglitazone dosage as loss of diabetes control may result. This, in turn, may lead to untoward diabetes associated complications. The FDA will continue to evaluate data from the ongoing ten-year epidemiologic study.

Click here to read the complete FDA Announcement.

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