The drug is produced by Japanese pharmaceutical company Takeda Pharmaceutical. The ban, by the Agence Francaise De Securite Sanitaire Des Produits De Sante, is effective July 11. The suspension also applies to a Takeda diabetes treatment, Competact, which contains metformin as well as pioglitazone. Pioglitazone is marketed as Actos in the United States and a number of other countries.
Both metformin and Actos are type-2 diabetes treatments. While the United States has no such restriction on Actos, which was the 10th-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion, the drug is currently under a long-term observational study by the Food and Drug Administration (FDA) over the risk of bladder cancer. Takeda's Actos patent expired in both the U.S. and Japan in January.
The AFSSAPS said it delayed the suspension for a month, so that patients who are currently using either of the medications could switch to different ones. The agency estimated that 230,000 patients in France alone were currently using one of the medications.
The European Medicines Agency said in a statement that its Committee for Medicinal Products for Human began its own independent review of Actos-containing medicines in March. It said that will now also assess the results of the French study.
Meanwhile, a Takeda spokesperson said, "We're working swiftly to deal with the orders raised by the French and German drug safety authorities."
Although Actos is primarily used to treat type 2 diabetes, it has also been used to treat non-alcoholic steatohepatitis (fatty liver), but only on an experimental basis. In addition to treating type 2 diabetes, Actos has also been found to reduce the risk of conversion from pre-diabetes to type 2 diabetes by 72 percent.
Type 2 diabetes, also known as Diabetes mellitus type 2, non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes, is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. Insulin resistance is a condition whereby the natural hormone insulin, becomes less effective at lowering blood sugars.
Frequently, type 2 diabetes is initially managed by increased exercise and dietary modification. However, if the lifestyle changes do not work, medications such as Actos, metformin, or glipizide may be required. In some cases, insulin will be prescribed.
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