Recalled Valsartan, Valsartan HCTZ Pose Unnecessary Risk for Consumers: FDA

Federal regulators are warning consumers about an ongoing investigation into recalled valsartan-containing drugs, including several generic Diovan equivalents that may contain impurities that increase the risk of cancer, indicating that the list of which versions of the hypertension drugs are impacted by the recall may change. 

In a safety alert issued late last week, the FDA notified consumers that three separate valsartan recalls have been issued so far, including variations labeled by Major Pharmaceuticals, Actavis and Solco Healthcare. However, there are 20 different variations/doses of the hypertension drug that may be impacted.

Due to manufacturing problems, the medications may have an impurity, known as N-nitrosodimethylamine (NDMA), which is not expected in valsartan drugs, and may result in cancer.

According to the FDA, some generic valsartan may have had the NDMA impurity for as long as four years. This has resulted in widespread concerns among patients and the medical community.

“The presence of the potentially cancer-causing NDMA was unexpected, and the agency believes the NDMA is related to changes in the way the active substance was manufactured. Some levels of the impurity may have been in the valsartan-containing products for as long as four years,” the FDA warns.

Consumers are being urged to contact their pharmacist or healthcare provider if they have questions or concerns, and compare information on prescription bottles with the current list of recalled valsartan drugs, which include:

• Valsartan 80 mg and 160 mg labeled as Major Pharmaceuticals (manufactured by Teva Pharmaceuticals USA);
• Valsartan 40 mg, 80 mg, 160 mg, and 320 mg labeled as Actavis LLC (manufactured by Teva Pharmaceuticals USA);
• 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 labeled as Actavis LLC (manufactured by Teva Pharmaceuticals USA);
• Valsartan 40 mg, 80 mg, 160 mg, and 320 mg labeled as Solco Healthcare LLC (manufactured by Prinston Pharmaceuticals Inc.)
• 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 labeled as Solco Healthcare LLC (manufactured by Prinston Pharmaceuticals Inc.)

The FDA is continuing to review and look at the levels of NDMA in the recalled pills, and the possible side effects for patients. The agency is also looking at what can be done to reduce or eliminate the impurity, thought to be a by-product of the manufacturing process, from future batches.

The agency also asks any patients or healthcare professionals to report any adverse events related to the use of the recalled drugs to the FDA’s MedWatch Adverse Event Reporting program.