FDA enters 22 countries recall of common heart drug

Valsartan is not patentable and is used as part of other generic medicines, but the FDA does not cover all medicines that contain the active ingredient. The US recall includes the versions of Valsartan available from Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. valsartan / hydrochlorothiazide (HCTZ) manufactured by Solco Healthcare and Teva Pharmaceuticals Industries sold.

"We carefully reviewed the valsartan-containing drugs sold in the US and found that the valsartan sold by these specific companies did not meet our safety standards, so we urged these companies to take immediate action to protect patients," said Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research.

In Europe and Asia, the Sandoz Valsartan and Valsartan / HCT film-coated tablets are recalled because they "do not meet our high quality standards". Pharmacies in the UK are advised to recall valsartan batches containing medicines from Dexcel Pharma Ltd and Accord Healthcare.
The recall is due to the presence of the contaminant N-nitrosodimethylamine (NDMA) found in the recalled products according to an FDA statement.

NDMA is an organic chemical that is in a family of powerful carcinogens. It has been used, inter alia, for the production of liquid rocket fuel, plasticizers and lubricants. It can also be produced unintentionally by certain chemical reactions and is a by-product in the manufacture of pesticides, the production of rubber tires or fish processing.

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Animal studies have shown that NDMA can be toxic and can cause tumors in the liver, kidneys and respiratory tract. It can also be potentially harmful to people in certain amounts. Exposure to high concentrations may cause liver damage, according to the US Department of Health, and is likely a human carcinogen.

Novartis spokesman Eric Althoff said after the first recall last week that the products sold in the US were not affected by this recall, the FDA's ongoing review and laboratory testing revealed a different outcome. "The presence of NDMA was unexpected and is believed to be related to changes in the way the drug was manufactured," the FDA press release states.

"The levels of NDMA found in the Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA," Althoff wrote in an e-mail on July 6. "There is no certainty about how much this contamination could potentially increase cancer risk. Therefore, the amount of NDMA found in the Valsartan API would not pose a significantly increased risk to patients taking Sandoz Valsartan and Sandoz Valsartan HCT film-coated tablets "

The FDA continues to investigate the drug.

"The FDA is committed to maintaining our gold standard for safety and efficacy, including our efforts to ensure the quality of medicines and safe manufacturing," said EU Commissioner. Scott Gottlieb on Friday. "If we find that there are quality defects in the drugs and manufacturing issues that can potentially cause risks to patients, we are determined to take immediate action to raise public awareness and facilitate product removal from the market Drugs are also working hard to ensure that the therapeutic needs of patients in the United States are met with adequate supplies of unaffected drugs. "

Patients are advised to talk with their doctor when taking the medicine. You should not stop taking medications without a doctor's permission. It would be dangerous if they could discontinue their medication without supervision, according to the American Heart Association.



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