Scary news for people suffering from high blood pressure; irbesartan seems to be leading tom cancer. The US Food & Drug Administration is going for a recall this medicine. SciGen has started the process of getting back certain types of irbesartan; medicines with the labels of Westminster Pharmaceuticals and GSMS Inc must be returned. FDA has released this list recently.
Irbesartan medicine is considered as an angiotensin 2 receptor blocker, in short known as ARB. This drug has the potential to compress the surrounding the blood vessels. This process prevents the muscle cells from bonding with the angiotensin, ultimately reducing the blood pressure levels.
Now FDA has discovered that this drug has N- Nitrosodiethylamine, which in short is known as NDEA. This is considered as a human and animal carcinogen. This component is used as a lubricant and as a component in gasoline which is used at industries. This has been declared by the National Institutes of Health. This is a non- valsartan medicine which contains the NDEA impurity. FDA had already started recalling medicine which consisted valsartan since the month of July.
These drugs are known to contain N- Nitrosodiethylamine, NDEA or NDMA. These chemicals are potential carcinogen according to the US Environmental Protection Agency. NDMA is a form of organic chemical which is used to produce liquid form of rocket fuel and is a by- product of pesticides and processed fish. All the ARBs are now tested by FDA to check for this kind of impurities. For this, the agency had to frame a new testing method as many of the components in the medicine are bought from China, namely the Zhejiang Huahai Pharmaceuticals.
FDA has stopped the import of any pharma product or finished good from this company. Aurobindo laboratory is engaged along with FDA to carry on the tests.