FDA issues recall for blood pressure medication due to cancer risk

FDA issues recall for blood pressure medication due to cancer risk

The recall in the United States includes versions of valsartan made by Solco Healthcare, Major Pharmaceuticals and Teva Pharmaceuticals Industries. Pharmacies in the United Kingdom are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.

The development comes following indications of the presence of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active pharmaceutical substance supplied by Chinese company Zhejiang Huahai Pharmaceuticals and used in these prescription medications.

The agency also said that patients taking valsartan, or medicines that use it as an ingredient, should continue taking it until they have a substitute.

Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved.

"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", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

A request for a class-action suit filed in the Montreal courthouse on Monday wants the manufacturers of a recalled heart medication, valsartan, to pay damages to Quebecers who took the drug.

TEVA is notifying its Direct Accounts by FedEx Overnight mailing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts of this product recall and making arrangements for impacted product to be returned to Inmar.

FDA issues recall for blood pressure medication due to cancer risk

Patients are advised to look at the company and the drug name mentioned on the label of their prescription to see whether the specific product is recalled or not.

The EMA said NDMA was an unexpected impurity that was not detected by routine tests carried out by Zhejiang Huahai, adding that the manufacturing changes introduced in 2012 were believed to have produced NDMA as a by-product.

Patients who take Valsartan should contact their doctor or pharmacist for an alternative treatment.

Blood pressure meds have been recalled over cancer fears after it was discovered that the widely prescribed drug may contain a carcinogen, Time magazine reported.

Major Pharmaceuticals said that the recalled products were distributed to "wholesale and retail facilities, including hospitals and pharmacies" nationwide.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

This information will be posted on the FDA's website.

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