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FDA warns of common blood pressure medication deficit due to recalls




The FDA is warning of the lack of blood pressure medicines containing valsartan, losartan and irbesartan.

The US Food and Drug Administration is warning of a shortage of a class of drugs used by millions to treat high blood pressure. The drugs known as ARBs, or angiotensin II receptor blockers, contain valsartan

"Valsartan products are in short supply, and we know that other types of products may fall into shortage soon," FDA Commissioner Dr. Scott Gottlieb and FDA Director of Drug Evaluation and Research Dr. Janet Woodcock said in a statement released Friday

This warning is a growing list of drugs containing valsartan, losartan and irbesartan that have been recalled from the market for containing an impurity that presents a cancer risk. discovered in July when the FDA lab tests determined that some medicines containing valsartan were contaminated with a chemical called NDMA, an environmental contaminant and possibly carcinogen

The FDA said its ongoing investigation had determined that impurities were generated in the manufacturing process and could have resulting from the reuse of materials such as solvents. "

The FDA is testing all ARBs for these impurities. The FDA placed Zhejiang Huahai Pharmaceuticals on an import alert at the end of September, meaning all active pharmaceutical products and finished products made by the company will not be allowed to enter United States. The FDA said the decision to investigate the "systemic problems of supervision that could have created the conditions for quality issues to emerge."

The FDA said the overall exposure to tainted drugs "seems to be small" but that it did not diminish the agency's concern about how the contamination occurred. The goal, the agency said, "is to balance the risk of patients ingesting low levels of impurities for a short period of time with the risk that there is a shortage of certain ARBs, which may impact patients "

As of now, the long-term risks posed by NDMA found in certain valsartan-containing drugs remain somewhat unknown, and the amount of NDMA consumed would play a role in those risks , Dr. Erin Michos, an Associate Professor and Associate Director of Preventive Cardiology at Johns Hopkins Medicine, told CNN in November

In other words, "the dose makes the poison," she said. "What we know about the dangers of this impurity comes mainly from laboratory studies. It is a toxin that can affect the liver and cause liver fibrosis or scarring and liver tumors in rats. So, it's assumed to be toxic to humans as well, "Michos said.

" In these animal studies, they usually give large quantities, so again, risk is probably not the same in humans, "she said.


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