Published: Tue, July 17, 2018
Medical | By

FDA recalls common heart drug due to cancer concerns

FDA recalls common heart drug due to cancer concerns

According to the FDA, an impurity called N-nitrosodimethylamine, or NDMA, was found in the recalled drugs.

NDMA has been classified by the World Health Organization's International Agency for Research on Cancer as a probable carcinogen to humans.

"The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured", the FDA said in its Friday announcement.

The specific products impacted are valsartan sold by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries, along with valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals.

"W$3 e've found that the valsartan sold by these specific companies does not meet our safety standards".

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. The agency said its drug shortages team is also trying to ensure an adequate supply of unaffected alternatives.

To determine if your specific medication has been recalled, look at the name of the drug and the company name on the prescription bottle label. The impacted medications were supplied by Teva Pharmaceuticals, and include Valsartan 80mg tablets and Valsartan 160mg tablets with the expiration dates of July 2018, February 2019, or May 2019.

Not all medications containing valsartan were included in FDA's recall.

Valsartan is also used in other generic medicine but not all medicines containing the ingredient are being recalled by the FDA.

Impacted medication includes, "40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiration dates from July 2018 to January 2020", according to a statement. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", FDA Commissioner Scott Gottlieb, MD, said in the statement.

According to our research and a declaration put forward by the pharmaceutical, Getz Pharma's Valsartan brands are manufactured using the raw material- Active Pharmaceutical Ingredients (APIs)- sourced from suppliers who are qualified as per World Health Organization guidelines.

Not all valsartan-containing medications are being recalled, however.

The FDA is continuing to investigate the issue and will add more information as it becomes available. The FDA has provided instructions on their website.

Like this: