REGULATORY LAW

FDA Examines Takeda’s Post-Marketing Data for Actos

Today, after examining the first 5 years of data from a 10-year post-marketing study of the diabetes drug, Actos, FDA announced more study may be needed to determine whether there is actually a link between the drug and an increased risk of bladder cancer.  Actos, known as pioglitazone, is prescribed for the lowering of blood sugar without increased risk of heart attack or stroke. 

According to the FDA, there was no statistically significant association overall between exposure to Actos and bladder cancer risk. However, data analysis of how long patients took Actos and how much of the drug they took during that time suggests there might be an increased risk of bladder cancer among patients who took it longest, and among those who consumed the highest cumulative dose of the drug.

FDA has not recommended any changes to the prescribed use or dosing of Actos at this time.

Looking for legal counsel on reporting study data or other FDA-related issues?  Visit us at  www.baxamlaw.com.

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