Recalls of certain drugs containing heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the US, as the FDA sought voluntary actions to take some affected drugs off the shelves due to the potential cancer risk.
In Europe, Novartis is recalling Sandoz' valsartan and valsartan HCT film-coated tablets in 23 countries.
Valsartan is used to treat high blood pressure and heart failure, according to the FDA.
NDMA has been classified by the World Health Organization's International Agency for Research on Cancer as a probable carcinogen to humans.
Because valsartan is used to treat serious medical conditions, patients taking the recalled products should continue taking their medicine until they have a replacement product, the FDA advises. If the medication's label does not explicitly name the manufacturer, or if there is any confusion whatsoever, the agency is advising patients to call their pharmacy and make sure their drug is not part of the recall.
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.
"W$3 e've found that the valsartan sold by these specific companies does not meet our safety standards".
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It is also a byproduct from pesticide manufacturing, or during the making of rubber tires or fish processing. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company.
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). The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
"The FDA is committed to maintaining our gold standard for safety and efficacy".
Doctors and their patients are warned to check their medications containing the ingredient valsartan as they might have been manufactured incorrectly.
As swift as the FDA's response appears to be, the whole issue has re-ignited an important conversation regarding how the USA can ensure the safety of imported drugs in the future - especially as imported drugs become more and more common.
"This is why we've asked these companies to take immediate action to protect patients". The agency encourages patients and health care professionals to report any adverse reaction to the FDA's MedWatch program.
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