EMA Updates on Pioglitazone and Varenicline

Shelley Wood

July 22, 2011

July 21, 2011 (London, United Kingdom) — The European Medicines Agency (EMA) has reached a decision in its pioglitazone (Actos, Takeda) review, opting to recommend new contraindications and warnings be added to the drug label noting that there is a small increased risk of bladder cancer with the diabetes drug [1].

The decision comes one month after an announcement by the FDA that it, too, was revising labeling and patient information. French regulators opted to suspend sales of the drug, while German regulators announced that pioglitazone should not be started in new patients.

The EMA's alert concludes that the "benefit-risk balance remains positive in a limited population of type 2 diabetics" and that "the small increased risk could be reduced by appropriate patient selection and exclusion, including a requirement for periodic review of the efficacy and safety of the individual patient's treatment." Risk factors for bladder cancer should be "investigated," particularly in elderly patients, before physicians move forward with the choice of pioglitazone, the EMA alert states.

Patients in whom pioglitazone should not be considered include those with current or a history of bladder cancer or those with uninvestigated macroscopic hematuria. Both the EMA and FDA have been reviewing pioglitazone's safety since 2010. Full details of the EMA alert are available on the agency's website.

For Varenicline

Separately, the EMA issued a second statement [2], this one focusing on the smoking cessation drug varenicline (Chantix [US] and Champix [EU], Pfizer) in response to a much ballyhooed meta-analysis published earlier this month in the Canadian Medical Association Journal [3], and reported by heartwire . The analysis, by Furberg and colleagues, found a small but significantly increased risk of cardiovascular events in people taking the drug.

In response, the EMA is telling prescribers that it believes the benefit-risk balance for Champix "remains positive," adding that the agency found a number of limitations in the meta-analysis, most striking of which was the low number of overall events. The agency's Committee for Medicinal Products for Human Use (CHMP) has, however, asked Pfizer to submit additional information on cardiovascular events that could be added to the product information.


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