- InPharm

07/11/2011 - The Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) last month moved to prevent Actos (pioglitazone), and Takeda’s related brand Competact, from being prescribed by suspending their use.

Now, with an EMA safety review still ongoing, AFSSAPS appears to have decided stronger local measures were necessary and asked for both drugs to be withdrawn altogether in France.

It first acted after a French study of public insurance data confirmed a slight increase in the risk of bladder cancer in patients treated with pioglitazone.

In a statement the company said: “Takeda is confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type II diabetes. We continuously monitor the safety and tolerability of all of our products and will continue to work with the EMA and other individual regulatory bodies to share and review all available data, and to determine appropriate next steps.”

Actos is currently Takeda’s best-selling product, bringing in Y387.9 billion ($4.83 billion) last year, but faces an increasingly uncertain future.

The French study last month persuaded Germany to recommend new patients are not given either Actos (pioglitazone) or Competact (piolglitazone and metformin).

Meanwhile, European regulatory advisers at the CHMP will pronounce on the two drugs’ safety at their next meeting later this month and a US review, though still ongoing, has already led to stronger safety warnings from the FDA.

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