High blood pressure has become pretty common these days and the medicine to control them such as Valsartan. The drug that contains a generic version of Valsartan has been recalled for potential risk of cancer after taking them to control blood pressure.
The F.D.A. said that the contaminants “are of special concern to global regulators because, unlike most impurities in drugs, they have the potential to cause harm at very low levels.”
A statement on the F.D.A. website explained the degree of risk: “Our scientists estimate that if 8,000 people took the highest daily valsartan dose (320 mg) that contained NDMA, for four years (the amount of time we believed the affected products had been on the U.S. market), there may be one additional case of cancer beyond the average cancer rate among Americans. Most patients who were exposed to the impurity through the use of affected valsartan received less exposure than in the scenario described above.”
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
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Tags: Valsartan Recall