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A drug commonly used to control blood pressure and help prevent heart failure was announced by the US Food and Drug Administration Friday, a week after 22 other countries have recalled it because the drug contains a potential risk of cancer. Valsartan is off patent and is used as a component of other generic drugs, but not all drugs containing the ingredient are involved, according to the FDA. The US recall includes versions of valsartan manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. and valsartan / hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
"We have carefully evaluated drugs containing valsartan sold in the United States, and we have found that the valsartan sold by these specific companies does not meet our safety standards.That's why we asked for these companies take immediate action to protect patients, "said Janet Woodbad, director of the FDA's Center for Evaluation and Drug Research
Novartis, the company that developed the UK's pharmacies. Kingdom are asked to recall the lots of valsartan containing medicines manufactured by Dexcel Pharma Ltd and Accord Healthcare.
The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), which has been found in the recalled products, according to a statement by the FDA
NDMA is an organic chemical that is in a family of potent carcinogens. r liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced by certain chemical reactions and is a by-product of the manufacture of certain pesticides, the manufacture of rubber tires or the processing of fish.
Animal studies have shown that NDMA can be toxic and cause tumors in the liver. leaflet. It can also be potentially dangerous for humans in certain quantities. According to the US Department of Health and Human Services, exposure to high concentrations can cause liver damage and is probably carcinogenic to humans.
Eric Althoff, spokesman for Novartis, said this recall, but the FDA's ongoing review and laboratory tests have concluded the opposite. "The presence of NDMA was unexpected and would be linked to changes in the way the active substance was manufactured," the FDA said.
"The quantities of NDMA found in the Valsartan API are much lower than the endogenous cumulative values." Althoff wrote in an e-mail on July 6. "There is no certainty as to how much this contaminant can potentially increase the risk of cancer in humans. Thus, the amount of NDMA found in the Valsartan API would not represent a significantly increased risk for patients taking Sandoz Valsartan and Sandoz Valsartan HCT Film coated tablets. "
The FDA drug investigation will continue.
" The FDA is committed to maintaining our standard of excellence in safety and effectiveness. This includes our efforts to ensure the quality of medicines and the safe way they are made, "said Commissioner Scott Gottlieb on Friday." When we identify failures in the quality of drugs and manufacturing issues that could create We are committed to acting quickly to alert the public and facilitate the removal of products from the market.While we are calling for the elimination of certain pharmaceuticals today, our team in charge of Medicines also strive to meet the therapeutic needs of patients in the United States by providing them with a sufficient number of unaffected drugs. "
doctor they take the drug. They should not stop taking medication without permission from a doctor. Getting rid of unattended drugs could be dangerous, according to the American Heart Association.
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