French Regulators Suspend Pioglitazone Citing Cancer Risk

Shelley Wood

Disclosures

June 09, 2011

June 9, 2011 (Paris, France) — The French drug regulatory authority, AFSSAPS, has suspended the marketing of pioglitazone (Actos, Takeda), following the recommendation of its Commission d’Autorisation de Mise sur le Marche (AMM) and National Commission on Pharmacovigilance. The decision was made after a study requested by AFSSAPS confirmed a small increase in bladder cancer among patients treated with the diabetes drug.

For now, AFSSAPS is recommending that patients taking pioglitazone not stop their treatment, but consult with their doctors to have their treatment adjusted. Physicians should not, however, prescribe any more drugs containing pioglitazone, the AFSSAPS statement notes.

AFSSAPS had sent a letter April 19 to physicians alerting them of the potential cancer risk. A subsequent review of pharmacovigilance data presented to the commission in recent months had led the AMM to conclude that the risks associated with pioglitazone use exceed its benefits. French physicians will receive a new letter in the next few days with details on the AFSSAPS decision.

Reporting on the French announcement earlier today, Bloomberg news service noted that the European Medicines Agency, which announced a review of pioglitazone in March, plans to discuss the safety of pioglitazone at its next meeting, the week of June 20, but has made no recommendations on the drug while a decision is pending.

As previously reported by heartwire , the FDA is also in the process of reviewing the safety of pioglitazone, citing preliminary epidemiological evidence that suggests that the diabetes medication may be linked to a higher risk of bladder cancer. An FDA spokesperson told heartwire today that the FDA is continuing to review the data, "and will make a determination on what regulatory actions are necessary once its review is complete. We anticipate this review to be complete within the next couple of months."

The FDA review is based on an ongoing 10-year observational cohort study as well as a nested, case-control study of the long-term risk of bladder cancer in roughly 193 000 patients with diabetes who are members of the Kaiser Permanente Northern California health plan. A preliminary analysis of these data showed an increasing risk of bladder cancer with pioglitazone exposure, a risk that reached statistical significance after 24 months.

Just last month, a new analysis using the FDA adverse event reporting system (AERS) found a significant increase in bladder cancer among diabetic patients taking pioglitazone.

Pioglitazone has been marketed in France both on its own (Actos) since 2000 and in combination with metformin (Competact) since 2006. The agency estimates that 230 000 patients in France are currently taking pioglitazone in some form.

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