Valsartan, found to be contaminated with N-Nitrosodimethylamine, an active ingredient present in the drug curing high blood pressure and heart failure.
The US. Food and Drug Administration announced for a recall of some medicines in July 2018, as they were reportedly contaminated with human carcinogenic substance that also induces cancer cells in rats. The impurity, N-Nitrosodimethylamine (NDMA), was found in some of the generic medicines made by Solco, Teva, and Major. All the contaminated drugs were found to be manufactured in China by the company, Zhejiang Huahai Pharmaceutical Co. Ltd.
NDMA, a semi-volatile compound, “may be an unintentional byproduct of the medications’ chemical manufacturing process,” said Jamie Alan, Ph.D., an assistant professor of pharmacology and toxicology at Michigan State University. NDMA, a probable human carcinogen, is a nitrate have specifically been linked to an increased risk of stomach, colon, and kidney cancers.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release said, “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards.”
The public are advised to discontinue from the usage of contaminated valsartan drug, however for those where it acts as life-saver could continue till their health providers comes with a possible replacement. The recall became a complicated process as there is a wide range of drugs with valsartan and is ubiquitously used. Meanwhile the FDA’s drug shortages team are maintaining efficient and adequate supply of the recalled medicines.