Tuesday, February 7, 2012

Pioglitazone Receives New Warnings Due to Slight Increase in Bladder Cancer Risk

The health review of the Type 2 diabetic drug, pioglitazone, performed by the European Medicines Agency, confirmed the drug remains a valid treatment option for certain patients while acknowledging a minimal increase in bladder cancer risk. The caveat in the conclusions of the health review centered upon advising physicians to use care and caution when prescribing the drug. The results further stated that those who are prescribed pioglitazone—especially those who take relatively high doses or have taken the drug for longer than a year—must have their overall health monitored closely. Exclusion of certain higher risk groups, such as the elderly is also recommended.

Assessing Risk Factors in Potential Patients
Physicians are warned to screen patients carefully, and avoid prescribing pioglitazone to those who have a history of bladder cancer or who currently have bladder cancer. Patients with uninvestigated macroscopic haematuria are also advised against taking pioglitazone. As stated, age carries a specific risk, as the elderly are already more likely to develop bladder cancer based solely on age. Because of this an alternative diabetes medication with less risk in this area should be prescribed. Patients taking Actos should undergo regular 3-6 month reviews to assess and monitor benefit vs. risk.

Sources of Information
In making its safety recommendations, the Committee for Medicinal Products for Human Use considered results of pre-clinical and clinical studies as well as spontaneous reports and epidemiological studies. The Scientific Advisory Group on Diabetes also weighed in with advice regarding pioglitazone. The CHMP concluded from this array of evidence that while there is a slight increase in bladder cancer among those taking pioglitazone, this risk exists primarily in those who take the drug for long periods of time or in relatively high doses. That being said, those who take the drug for a short amount of time cannot be excluded from the risks.

Further Research Indicated
The CHMP has indicated that further research and controlled studies are necessary to fully explore the risk of bladder cancer in those taking pioglitazone as compared to those who take other diabetic drugs or those who take no diabetic drugs. It is expected that the issue of whether prolonged use or high cumulative doses are more likely to cause bladder cancer will be more clearly addressed in subsequent studies.

The Bottom Line
Both the SAG and CHMP agree that among patients who will not receive adequate treatment from other diabetic drugs—and who are neither elderly nor have a history of bladder cancer—pioglitazone is still considered the best therapy. While patients must be carefully screened and monitored, the benefits of pioglitazone still outweigh the potential risks.

Author: Sullo & Sullo Attorneys

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