EMA opens Actos safety probe after cancer reports

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Takeda Pharmaceuticals' diabetes drug Actos may have come out on the better side of its controversy-plagued rival Avandia. But that doesn't mean Actos doesn't have problems of its own. European regulators have now launched a formal probe into a potential link between Actos and an increased risk of bladder cancer.

The risk factor was flagged early on, the European Medicines Agency said in a statement, and regulators have been keeping an eye on the data since the drug was approved in 2000. Takeda is now in the middle of a 10-year study of cancer rates in Actos patients.

So far, no clear link between the drug and bladder cancer has cropped up. But an increase in spontaneous reports from the field prompted the EMA to look at the drug. "The Committee will now review all available data thoroughly, including published data, non-clinical and clinical data, post-marketing reports and pharmacoepidemiological studies, and will assess their impact on the balance of risks and benefits of these medicines," according to an agency statement.

Actos is in the same class of medicines as Avandia, the GlaxoSmithKline drug that came under scrutiny for increased cardiovascular risks in 2007, and last year was withdrawn in Europe and severely restricted in the U.S. Coincidentally, a new Lancet meta-analysis just confirmed that Avandia patients have had a higher risk of heart troubles than Actos patients.

- check out the EMA statement
- see the Reuters story
- get more from MedPage Today

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