Valsartan Recall

Valsartan Recall  Monmouth Cardiology Associates

Valsartan Recall 

Prior to calling our office, patients are instructed to contact their pharmacy to see if their medication is manufactured by one of the pharmaceutical companies.  If the drug is affected, please call the office and speak with a nurse for direction. 

Valsartan, a, common drug used to control blood pressure and help prevent heart failure was recalled by the US Food and Drug Administration on Friday, a week after 22 other countries recalled it because the drug contains a chemical that poses a potential cancer risk.

The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

"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. This is why we've asked these companies to take immediate action to protect patients," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, according to an FDA statement.NDMA is an organic chemical that is in a family of potent carcinogens. Animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen, according to the US Department of Health and Human Services.

Ideally, patients should contact their pharmacy to see if their medication is from one of the affected Pharmaceutical Companies, because not all Pharmaceutical companies were affected. In addition, the medication that the patient has at home IS NOT affected, according to the Valsartan drug rep that was contacted today. Only new prescriptions sent out since last week were affected, so the patient may still safely take the prescription that they have at home as long as they have had them for over a week.

Lastly, Entresto and Exforge should not be affected by this.

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