EU Agency Requests New Warnings To Be Placed on Actos

The U.S. Food and Drug Administration had announced recently that it would be adding information to the drug's label, but would keep the product on the market for the time being.While the type 2 diabetes medication Actos had been under pressure from European authorities, the agencies within the continent have finally decided to push harder for new warning labels to be put on the drug, Reuters reported.

Takeda Pharmaceutical's Actos has been linked to an increase in the likelihood of developing bladder cancer, a risk that the European drug regulators have said needs to be outlined on a new warning for the medication, according to the news source.

The Japanese company's Actos medicine remains a source of treatment for diabetes, but the side effects have persuaded the European Medicines Agency (EMA) to call for new warnings to alert citizens of the risks. By placing these safety messages with the drug, the EMA believes that patient selection and exclusion could dictate who is prescribed, reported Reuters.

By giving the doctors and hospitals the warning, the EMA hopes that these medical professionals will examine their patients and make the right choice about possibly prescribing Actos, considering the dangerous side effects, the news source reported.

The EMA noted that with the new warning label could come a mandatory period of review of the efficacy and safety of the individual patient's treatment, if they were to be prescribed to the drug at all, according to Reuters.

This announcement came on the heels of France's decision to recall the drug due to the dangerous side effects, but many EU countries are waiting for further word from the EMA before they take action, the news source reported.

"Takeda is confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes, and remains committed to pioglitazone and pioglitazone-containing medications," the company said in a statement, according to Reuters.

The U.S. Food and Drug Administration had announced recently that it would be adding information to the drug's label, but would keep the product on the market for the time being, the news source reported.

UK regulator MHRA has already advised patients to stop taking the drug until they see their doctor, along with warning them to report visible blood in their urine along with any problems that individuals have when urinating, according to WebMD.

The agency has stressed that patients should be wary of the benefits of the drug in the face of the considerable risks that are associated with it, the medical website reported.