Recalled Heart Drug Found with yet Another Impurity by the FDA


Another unpredicted impurity has been found by the US Food and Drug Administration (FDA) in three batches of the recalled valsartan drug, which belongs to Torrent Pharmaceuticals. There are certain pills that contain valsartan and they are taken by people who have high blood pressure and heart failure. Since July this year, these pills have been under a voluntary recall. What was found in these drugs was an impurity called NDMA, which is considered to be a possible carcinogen by the US Environmental Protection Agency.

What do we know so far

Up until this point, what we know is that not all versions of the drugs were recalled. This Thursday, another impurity, NDEA, was found in three sets of the drugs created by Torrent Pharmaceuticals. This second impurity that was discovered is also suspected to be a carcinogen. The reason why the agency wanted to test the recalled products that were not previously recalled for the substance was that Zhejiang Huahai Pharmaceuticals found this impurity in a few lots of its valsartan active ingredient. However, not all sets were affected.

What do you need to do if you take valsartan

After the second impurity was discovered, Health Canada is offering some guidance on what those who take the affected valsartan medication have to do. In case you are concerned that your drug is on the recall list, you should contact your doctor or pharmacist before you change anything in your treatment. Since not every valsartan drug was implicated in the recall, they could try to give you another version of the drug from another company. In the situation that you already know that your drug is on the recall list, the FDA’s advice is to continue to take the drug until your doctor will give you a replacement.


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