Mylan recalls 'made in India' BP drug from US due to cancer
Drug major Mylan has said it was voluntarily recalling over 1.2 million bottles of three anti-hypertension drugs of the different count from the US market due to the presence of an impurity, N-nitrosodiethylamine (NDEA), which is believed to cause cancer.

According to the notification put up by US FDA, Valsartan, the Active Pharma Ingredient in all the three drugs, Amlodipine and Valsartan, Valsartan and Valsartan and Hydrochlorothiazide Tablets, was manufactured by Mylan Laboratories Limited in its Nashik plant.

“Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC),” Mylan said in its letter to the FDA.

Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

With inputs from:-
1. https://pxmd.co/M9NBE
2. https://pxmd.co/HBZ3s
Like
Comment
Share