Food and Drug Administration dept. of USA has issued a public directive that there could be severe shortage of certain class of drugs used by millions of people to keep their high blood pressure in check. FDA commissioner Dr. Scott Gottlieb and Dr. Janet Woodcock director of research and drug evaluation stated that drugs which contain valsartan, losartan and also irbesartan have been ordered by FDA to be recalled as they contain an impurity which is a cancer risk. This discovery was made by FDA during July last year when some medicines containing valsartan were found to be contaminated with NDMA chemical which is a carcinogen as it is a contaminant. FDA has stated that its investigation revealed that these impurities occurred during the manufacturing process of these drugs that could be due to reuse of solvents. FDA said that further tests are being done on all ARB’s for impurities and has also devised a special test on finding out some of these ingredients were imported from a Chinese company.
After confirming that all ingredients from Zhejiang Huahai Pharmaceuticals were impure FDA has issued a blanket ban on all imports of the company whether it is raw ingredients or finished products and declared that none of its products can be allowed into USA. The agency said that though the exposure to these drugs is small it did not diminish its concern over contamination. As risks of NDMA in specific valsartan drugs are unknown researchers are not yet sure about actual dose of NDMA which can make it lethal. Previous tests have shown that NDMA is a toxin that causes liver fibrosis and leads to liver tumors in lab rats so it is likely to cause similar issues to humans. But some researchers say that as lab animals are given large quantities during experiments the risk may not be much for humans.
