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FDA enforces recall of hypertension drugs over cancer-causing impurities


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A recall of 42 batches of hypertension drugs has been enforced by the Food and Drug Administration (FDA) from five pharmaceutical manufacturers following the discovery of potentially carcinogenic impurities. The decision came after the detection of azidomethyl biphenyl tetrazole (AZBT) impurities in some models of irbesartan, a drug used to control high blood pressure.

 

Acting secretary-general of the FDA, Narong Aphikulvanich has confirmed the recall, citing increased cancer risk for patients as the primary reason. Despite the recall of certain models, Narong assures that other FDA-approved models of irbesartan remain safe for consumption.

 

In response to the contamination, the FDA has instructed manufacturers of irbesartan to conduct thorough inspections for AZBT impurities. They are also required to replace contaminated ingredients with non-AZBT alternatives and to revisit their market distribution of the drug, reported Bangkok Post.


The FDA’s call to action was prompted by the examination of irbesartan samples collected from every manufacturer. Subsequent analysis by the Department of Medical Sciences revealed that certain models of the drug contained impurities at levels exceeding international safety standards, thereby increasing cancer risks.

 

by Mitch Connor

Picture courtesy of MGR Online

 

Full story: The Thaiger 2023-10-23

 

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