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13 July 2018. EMA (European Medicine Agency) and US FDA ordered recall of Valsartan because it was found to have traces of the impurity NDMA (Nitroso-Di-Methyl-Amine) which was classified as ‘probable human carcinogen’. Most brands containing Valsartan were taken off from the markets around the world.
This news was not yet old when the following flash came in.
30 October 2018. Sciegen Pharmaceuticals Inc. voluntarily recalled Irbesartan containing products due to detection of trace amounts of N-NitrosoDi-Ethyl-Amine (NDEA) impurity in API which is considered to be ‘probable human carcinogen.
8 November 2018. Sandoz voluntarily recalled Losartan Potassium due to detection of trace amounts of NDEA (same as Irbesartan) impurity found in the Active Pharmaceutical Ingredient (API).
That makes it three major molecules. We keep fingers crossed for Olmesartan and Telmisartan and Candesartan. It would not be surprising to see something similar reported about them because all ‘Sartans’ share the same chemical structure and are likely to share the same chemical route for development.
The Angiotensin Receptor Blockers (ARBs) have been around for over two decades. They came as a sequel up of Angiotensin Converting Enzyme Inhibitors (ACEIs) which were a big breakthrough in the treatment of hypertension.
Currently, these drugs from the largest used group world over. The uncertainty and panic caused by these events is likely to have a major impact. A lot of hypertensive patients in countries like ours are not educated enough and do not have access to information.
It should be clearly understood that there is no new issue with the safety of these drugs. The problem of impurity, which is basically residual, is what has caused the recall. The impurity comes from the process of producing the API through a certain chain of events.
The following steps are coming into place and should be done where not done as yet.
- Chemical Testing. The API producer should do stringent testing and ensure and certify absence of impurity. The regulatory bodies should in importing countries should facilitate and insist on chemical testing to make doubly sure that NDMA and NDEA is not present.
- Pharmaceutical Manufacturers. The manufacturers of products containing ‘sartans’ should insist on getting materials which are certified to be free of NDMA and NDEA. It may increase the cost a little, but it must be done.
- Patient Awareness and Education. This is the most important thing to do and the responsibility should be shared by the government, Pharma companies, media and NGOs engaged in healthcare programs.
There is no doubt that this news is hugely distressing. However, with concerted and coordinated efforts, the situation can be salvaged to the benefit of all stake holders.