FDA recalls blood pressure, heart failure medications after cancer-causing agents found

Henrietta Strickland
July 16, 2018

The DRAP Recall alert stated that a total of nine pharmaceutical companies in Pakistan are on the DRAP recall list and this list does not include Getz Pharma and its products: Cova, Covam and Cova-H.

FDA announced a voluntary recall of common heart drug with the active ingredient valsartan.

The recall doesn't include all products containing valsartan; valsartan medications made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. are being recalled, along with valsartan/hydrochlorothiazide (HCTZ) from Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

The authority says the drug, valsartan, has chemicals that may cause cancer and has also recalled it from markets.

NDMA is classified as a probable human carcinogen based on lab tests. "This is why we've asked these companies to take immediate action to protect patients", explained Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

The company's manufacturing facility is pre-qualified and approved by WHO Geneva, as well as from a member country of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

FDA's announcement was made a week after 22 other countries had conducted their respective recalls of valsartan. United Kingdom pharmacies have been advised to recall valsartan-containing drugs made by Dexcel Pharma Ltd and Accord Healthcare, while the European Medicines Agency is investigating drug products supplied by Zhejiang Huahai Pharmaceuticals; a company in Linhai, China.

The FDA believes this sudden presence of NDMA is because of the way the substance was manufactured.

Novartis spokesman Eric Althoff said after the initial recall last week that products sold in the USA were not affected by this recall, but the FDA's ongoing review and laboratory tests found otherwise. Previous trials with animals showed NDMA can trigger the growth of tumors in the liver, kidney, and respiratory tract.

"The FDA is committed to maintaining our gold standard for safety and efficacy".

The move comes after the United States Food and Drug Administration recalled the drug on Friday for containing an "impurity".

Windsor Regional Hospital is asking patients to continue taking their heart medications prescribed by their doctor, even though an ingredient may have been recalled by the manufacturer.

Patients should look at the drug name and company name on the label of their prescription bottle to determine whether their medicine is part of the recall.

Patients should still contact their health providers before deciding to stop ingesting medicine with valsartan. They should not discontinue taking medication without a doctor's permission.

Other reports by Click Lancashire

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