Medicine

56,000 bottles of blood pressure medication recalled

56,000 bottles of blood pressure medication recalled

Another blood pressure medication has been recalled over concerns it could contain trace amounts of carcinogens.

The toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero's losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.

The latest recall is for 38 lots of Valsartan and Amlodipine and Valsartan tablets produced by AurobindoPharma USA due to "the detection of trace amounts of an unexpected impurity found in the finished drug". The company said it hadn't received any reports of patients being harmed related to the recall.

The recall affects 25mg, 50mg, and 100mg tablets, according to a notice posted on the US Food and Drug Administration's website.

A series of drugs have been identified as potentially risky since an initial recall began seven months ago. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines. That said, any presence of such impurities in drug products is not acceptable.

The movie version of Sonic the Hedgehog has leaked
The page where the images first appeared has since been removed, but they managed to make their way onto the internet anyway. Sonic's co-creator Yuji Naka even tweeted his slight disappointment, saying the design needs "more balance".

"Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients".

The agency and companies are testing all ARBs for impurities.

"Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA". Friday, the FDA said it estimated the same for NMBA.

Manufacturers are compelled to report impurities, for example, and the agency inspects factories on a risk-prioritized basis. Other people are getting their prescriptions changed.

The FDA says no one has reported any adverse effects from the drug and patients should speak with their doctor to discuss the recall before they stop taking the drug. The company also makes losartan for other Indian drugmakers, including Torrent Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., that has been recalled for containing NDEA.


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