New Delhi: Teva Pharmaceutical Industries Ltd is recalling certain combinations of blood pressure drug valsartan in the United States following the detection of a probable cancer-causing impurity, the latest global recall of the medicine.
The Israeli drugmaker will recall all lots of amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combination tablets due to an impurity in an ingredient made by an India-based unit of Mylan, the U.S. Food and Drug Administration (FDA) said on Tuesday.
The European Union last week effectively banned Mylan valsartan in the United States. Mylan recalls batches of blood pressure medicine in U.S sales of valsartan made by the Mylan India unit after some batches were found to contain the same impurity, N-nitrosodiethylamine.
Teva has not received any reports of adverse events signalling a potential link or exposure to valsartan, the health regulator said.
Patients are advised to continue taking their medication as the risk of harm may be higher if the treatment is stopped immediately without any comparable alternative treatment, the FDA said.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global company in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory.
Medical Dialogues team had earlier reported that Over the past year, global health authorities have been cracking down on valsartan and drugs containing the substance as an active ingredient after several batches were found to contain NDEA and a second possible carcinogen, N-nitrosodimethylamine (NDMA).
The U.S. FDA last month halted imports of drug ingredients or medicines containing ingredients produced at a factory belonging to a Chinese bulk manufacturer of valsartan, Zhejiang Huahai Pharmaceuticals.
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