Valsartan, a popular drug used to control blood pressure and prevent heart failure, is being recalled because some versions may contain a chemical that poses a potential cancer risk. The U.S. on Friday joined the recall announced earlier in Germany, Canada, France and other countries.
The recall is due to an impurity, N-nitrosodimethylamine (NDMA), found in some but not all drugs containing valsartan. NDMA is classified as a probable human carcinogen based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, the Food and Drug Administration (FDA) said in a news release.
The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Other products are not affected at this time.
|Valsartan||Teva Pharmaceuticals Industries Ltd.|
|Valsartan/Hydrochlorothiazide (HCTZ)||Solco Healthcare|
|Valsartan/Hydrochlorothiazide (HCTZ)||Teva Pharmaceuticals Industries Ltd.|
What to do
If you are taking valsartan, you should look at the company name on the label of their prescription bottle. If one of the companies above is listed, you should contact your doctor or pharmacist who may prescribe another medication.
Since valsartan is used to treat serious health conditions, you should not stop taking your medication unless told to do so by your physician or pharmacist.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The European Medicines Agency discovered the problem in tests it conducted on drug from a Chinese supplier, Zhejiang Huahai Pharmaceuticals. The presence of NDMA was “unexpected and is thought to be related to changes in the way the active substance was manufactured,” the agency said.
The recall affects only products containing valsartan from Zhejiang Huahai.
“The FDA is committed to maintaining our gold standard for safety and efficacy. 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. “As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”