Actos Recalled in Europe, FDA Adds to Warning

By Rheingold Giuffra Ruffo & Plotkin LLP

An important medical update for those taking type-2 diabetes pills: media outlets are reporting that specific brands of these diabetes pills are linked to breast and bladder cancer. Takeda Pharmaceuticals is officially withdrawing Actos — a drug that treats type-2 diabetes by helping control blood sugar levels in conjunction with diet and exercise — from the market in France after studies indicated that patients taking the drug had a higher risk of bladder cancer.

The study was commissioned by the French government in June, examining diabetics taking Actos in comparison with diabetics taking other drugs, and resulted in French regulators asking Takeda to remove Actos from the market entirely. While Takeda and French authorities work together on the withdrawal, prescriptions for Actos can no longer be written except for people already on the drug. Following the release of the recent French Actos study, the FDA said information regarding the link between Actos and bladder cancer would be added to the warning section of the label while they review the drug.

Here in the US, the FDA is weighing whether to clear sales of a new diabetes pill made by Bristol-Myers Squib and Astra Zeneca that may cause breast and bladder cancer. The FDA is focusing on safety concerns in a review of dapagliflozin, following an increased scrutiny of diabetes pills since top-selling Avandia was tied to heart attacks in 2007. See the FDA Safety Annoucement.

There are an estimated 25.8 million people in the US that have diabetes, mostly type-2 due to being overweight and sedentary, according to the National Institutes of Health. The disease is caused by an inability to use the body’s insulin to break down blood sugar into energy, which can increase the risk of heart disease, stroke, and kidney damage.

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