The FDA issued a press release July 13 announcing the voluntary recall of several drug products containing valsartan.
Valsartan is a generic, commonly used member of the drug class of angiotensin receptor blockers (ARBs) used for high blood pressure and heart failure and I have many patients on it. The brand name form of it (Diovan) does not appear to be on the recall list.
Per the FDA, the recall was
due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) 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.
If you are taking it read the following from the FDA to see if your particular manufacturer is included in the recall.
If your valsartan has been recalled contact your doctor for instructions. For my patients, most likely I will substitute another ARB called losartan which has very similar effectiveness and side effects.
Information for Patients and Health Care Professionals From The FDA
- Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
- To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
- If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
- Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.
|Valsartan||Teva Pharmaceuticals Industries Ltd.|
|Valsartan/Hydrochlorothiazide (HCTZ)||Solco Healthcare|
|Valsartan/Hydrochlorothiazide (HCTZ)||Teva Pharmaceuticals Industries Ltd.|
“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.