European Medicines Agency remains cautious toward pioglitazone, but hesitates to issue outright ban despite Actos bladder cancer evidence

(Oct. 25, 2011)  After earlier sending signals that it might move to outlaw the drug pioglitazone (Actos), the European Medical Agency backed off last week from recommending any such ban on the grounds that Type 2 diabetics who respond only to this particular pharmaceutical should not lose access to it, despite mounting evidence linking Actos to bladder cancer.

The EMA announced Oct. 21 that, because some patients cannot be adequately treated by other treatments, pioglitazone should remain available as a treatment option.

However, the agency at the same time refused to rescind its July issuance of new warnings and contraindication recommendations for the drug.

Those warnings came in response to findings linking pioglitazone to a small increased risk of bladder cancer.

“Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment,” the agency said in a news release. “Prescribers are advised not to use these medicines in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic haematuria.

“In light of age-related risks, the balance of benefits and risks should be considered carefully both before initiating and during treatment in the elderly.

“Prescribers should review the treatment of patients on pioglitazone after three to six months (and regularly afterwards) to ensure that only patients who are deriving sufficient benefit continue to take it.”

The EMA conceded there exists a need for further analysis of the types, evolution and severity of bladder cancer in patients treated with pioglitazone compared to diabetics treated without it.

The EMA’s updated recommendation next will be sent to the European Commission for a vote.

Pioglitazone marketed under the brand name Actos was authorized for sale in the European Union in 2000. The drug is made by Takeda Pharmaceutical Co., based in Osaka, Japan. It has been the subject of litigation in the U.S. since the Actos-bladder cancer link came to light.

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