After Losartan, more blood pressure drugs face recall over cancer fears

Yet another blood pressure medication recalled for cancer risk

FDA recalls another blood pressure medication over concerns of cancer-causing ingredients

In a statement, FDA Commissioner Scott Gottlieb explained that the agency has been carrying out a series of investigations for several months after various companies began announcing their voluntary recalls.

Problems with potential cancer-causing agents in blood-pressure medications first cropped up in July, when an ARB called valsartan was recalled by Chinese drugmaker Zhejiang Huahai Pharmaceutical Co. Ltd.

AurobindoPharma, which is based out Hyderabad, India, distributed its tainted products to US pharmacies under the names of AurobindoPharma USA and Acetris Health LLC. FDA scientists have developed novel and sophisticated testing methods specifically created to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines.

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The U.S. Food and Drug Administration announced two more recalls of blood pressure medication Friday because potentially carcinogenic impurities were found in them.

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 FDA has said it thinks the potential carcinogens, known as nitrosamine impurities, are a result of the manufacturing processes the companies used.

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Recent FDA analyses of NDMA and NDEA in the recalled drugs have found that "overall, the risk to individual patients is very low", but the agency added that those findings don't diminish the significance of this issue and that it continues to evaluate the risks posed to patients. The FDA has a comprehensive list of medicines under recall.

The FDA also said it is working to develop testing methods to detect other cancer-causing impurities. Friday, the FDA said it estimated the same for NMBA. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future".

Hetero Labs Limited also manufactured the active ingredient in the single lot of Losartan that Macleods Pharmaceuticals Limited recalled last week for having too much NDEA.

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