What to Know
- The FDA announced a voluntary recall of several medicines containing an ingredient used to treat high blood pressure and heart failure
- The FDA issued an alert Friday regarding various drug products containing valsartan due to an impurity
- The impurity known as N-nitrosodimethylamine, or NDMA, is classified as a possible human carcinogen based on laboratory tests
The U.S. Food and Drug Administration has announced a voluntary recall of several medicines containing an ingredient used to treat high blood pressure and heart failure.
The FDA issued an alert Friday regarding various drug products containing valsartan due to an impurity. However, not all products containing the active ingredient are being recalled.
The impurity known as N-nitrosodimethylamine, or NDMA, is classified as a possible human carcinogen based on laboratory tests.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
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The FDA says that the presence of NDMA was unexpected and a probable result of changes in the way the substance was manufactured.
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The agency’s review of NDMA is ongoing and has included investigating the levels of NDMA in the recalled products and the possible effect on patients who have been taking them.
Additionally, the FDA is investigating what measures can be taken to reduce or eliminate the impurity in future batches.
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The FDA also alerts that since valsartan is used in medicines used to treat serious conditions, patients should continue to take the medicine until they have a replacement product.
The recalled products are:
- Medicine: Valsartan Company: Major Pharmaceuticals
- Medicine: Valsartan Company: Solco Healthcare
- Medicine: Valsartan Company: Teva Pharmaceuticals Industries Ltd.
- Medicine: Valsartan / Hydrochlorothiazide (HCTZ) Company: Solco Healthcare
- Medicine: Valsartan / Hydrochlorothiazide (HCTZ) Company: Teva Pharmaceuticals Industries Ltd.
The FDA urges those who have been taking the recalled medicines to follow the recall instructions provided by the specific company, which are posted on the FDA’s website.
Patients should also contact their health care professional.
