FDA announces voluntary recall of several medicines containing valsartan

FDA announces voluntary recall of several medicines containing valsartan

The Drug Regulatory Authority of Pakistan has stopped nine companies from producing and distributing a drug used to control blood pressure and prevent heart failure because it may cause cancer. N-nitrosodimethylamine (NDMA) was found in the recalled products.

The human carcinogen NDMA is an organic chemical that is also used to make liquid rocket fuel, softeners, and lubricants.

According to the FDA, the presence of NDMA is these drugs was unexpected.

The firms recalling products include Major Pharmaceuticals' Valsartan, Solco Healthcare's Valsartan and Valsartan/Hydrochlorothiazide (HCTZ), and Teva Pharmaceuticals Industries' Valsartan and Valsartan/Hydrochlorothiazide (HCTZ).

It is also a byproduct from pesticide manufacturing, or during the making of rubber tires or fish processing. The agency also recommends that consumers determine if they are taking a recalled product, find the company-specific recall instructions, and contact their pharmacy and physician. 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.

The FDA points out that not all products containing valsartan are being recalled.

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"The FDA's review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company", the FDA said Friday in a news release.

In Europe, Novartis is recalling Sandoz' valsartan and valsartan HCT film-coated tablets in 23 countries.

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

"The FDA is committed to maintaining our gold standard for safety and efficacy". The FDA said it is now investigating the levels of NDMA in the recalled products, assessing the effect on patients and working with Huahai to solve the problem in future batches. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", said FDA Commissioner Scott Gottlieb, M.D.

Patients are advised to talk to their doctor if they are taking the medication.

As swift as the FDA's response appears to be, the whole issue has re-ignited an important conversation regarding how the United States can ensure the safety of imported drugs in the future - especially as imported drugs become more and more common.

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