The presence of a potentially cancer-causing impurity in some brands of the blood pressure and heart failure drug valsartan may have been present in the products for as long as four years, the Food and Drug Administration (FDA) announced in a Safety Alert and update about the agency’s ongoing investigation into drugs possibly tainted with N-nitrosodimethylamine, or NDMA.
Last week, the FDA announced three recalls related to the NDMA impurity detected in the valsartan active pharmaceutical ingredient (API):
- Teva Pharmaceuticals USA labeled as Major Pharmaceuticals – recall at the retail level because these products are only used in facilities where they are directly administered to patients by health care professionals – valsartan 80 mg and 160 mg.
- Prinston Pharmaceuticals Inc., labeled as Solco Healthcare LLC – recall is at the consumer/user level – valsartan 40 mg, 80 mg, 160 mg, and 320 mg; and valsartan/HCTZ 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg.
- Teva Pharmaceuticals labeled as Actavis LLC – recall is at the consumer/user level – valsartan 40 mg, 80 mg, 160 mg, and 320 mg; and valsartan/HCTZ 80/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg.
The impurity was traced back to the API manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, and affects various brands of valsartan. The FDA reported that the presence of NDMA in the drugs was unexpected, and was likely related to changes in the way the active substance was manufactured.
Patients should talk with their pharmacist or doctor if they have questions about their medication. The agency also advised patients with affected products be switched to valsartan-containing medicines made by other companies or consider other available treatment options for their condition
Valsartan is used to treat high blood pressure and heart failure. Patients should be aware that not all products containing valsartan are being recalled.
FDA Safety Alerts