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July 18, 2018
On July 13, the Food and Drug Administration (FDA) announced that it had asked three manufacturers of valsartan medications — which are approved by the FDA to treat hypertension and heart failure — to recall all unexpired lots of these products because the drugs had been found to be contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer). Importantly, not all valsartan products needed to be recalled.
The FDA...
July 18, 2018
On July 13, the Food and Drug Administration (FDA) announced that it had asked three manufacturers of valsartan medications — which are approved by the FDA to treat hypertension and heart failure — to recall all unexpired lots of these products because the drugs had been found to be contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer). Importantly, not all valsartan products needed to be recalled.
The FDA action follows swifter actions by drug regulatory agencies in Europe and Canada. On July 5, the European Medicines Agency (EMA) announced that national authorities in European Union countries were recalling several valsartan medications for the same reasons cited by the FDA, as did Health Canada on July 9.
According to both the EMA and Health Canada, the source of the contamination in the recalled products was the bulk active ingredient valsartan that had been produced by the Chinese company Zhejiang Huahai Pharmaceuticals. The detection of NDMA in the valsartan was unexpected and is thought to be related to changes in the way the active ingredient was manufactured. How long contaminated valsartan products have been on the market is unclear.
The three companies asked by the FDA to voluntarily recall their valsartan products in the U.S. were Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceutical Industries. The recalled products are various doses of single-ingredient valsartan tablets and combination valsartan-hydrochlorothiazide tablets. Health Canada announced that valsartan products marketed in Canada are being recalled by five companies: Act, Pro Doc Limitee, Sandoz, Sanis, Sivem Pharmaceuticals and Teva.
Note that other manufacturers of valsartan-containing products obtain the bulk active ingredient valsartan from other companies, and their products are not subject to these recalls.
Valsartan is a one of several hypertension drugs called angiotensin receptor blockers (ARBs) available in the U.S. that all work the same way. Note that we have designated one ARB, olmesartan (AZOR, BENICAR, BENICAR HCT, TRIBENZOR), as Do Not Use because it can cause a serious gastrointestinal disorder called sprue-like enteropathy.
What You Can Do
Because valsartan is used to treat serious medical conditions, if you are taking a recalled valsartan-containing product, you should continue taking it until you can get a replacement valsartan or another ARB product.
To determine whether a specific valsartan product has been recalled, you should look at the drug name and company name on the label of your prescription bottle. If the information is not on your bottle, you should contact the pharmacy that dispensed the medication.
Read the FDA’s announcement here.
Read the EMA’s announcement here.
Read Health Canada’s announcement here.
