According to the American Heart Association, an estimated 103 million adults have high blood pressure in the U.S. This is nearly half of all adults in the country. On July 13th, the FDA announced a voluntary recall on some products that contain the active ingredient valsartan, which is a common medicine used to treat high blood pressure and heart failure. This article will tell you everything you need to know about the recall, including FDA updates and how this will impact your treatment.
The recall was issued due to the presence of an impurity, called N-nitrosodimethylamine (NDMA), that was found in the products.These recalled products were supplied to companies by Zhejiang Huahai Pharmaceuticals in China. The presence of this impurity was thought to be a result of the manufacturing process. NDMA is classified as a probable human carcinogen, meaning that it is a substance that could cause cancer. Although the amounts of NDMA detected were small, the FDA considers them to be unacceptable and issued the recall.
The FDA is continuing to investigate the recall and post updates online at this time. Not all medications that contain valsartan are involved in the recall, so it is important to check with your doctor and pharmacist to see if you are impacted by the recall. Below is a link to the FDA’s list of recalled products.
This recall has left patients with many questions and concerns. The biggest concern is the cancer risk. According to the FDA, patients who were prescribed one of the recalled products have a very low cancer risk. The FDA estimates that 8,000 patients would need to take the recalled valsartan 320 mg daily, which is the highest dose available, for 4 years to possibly lead to one additional lifetime diagnosis of cancer.
Patients can reference the link above or contact the pharmacy to determine if they are affected by the recall. For those who are taking the recalled valsartan-containing medicines, the FDA recommends that patients should continue taking their medicine until they have a replacement product. Valsartan is used to treat serious conditions, such as high blood pressure or heart failure, and should not be suddenly stopped without a replacement medication. There are other medications in the same drug class as valsartan that are safe, affordable alternatives for patients to use in place of their recalled medication.
If you have any additional questions about the Valsartan Recall, please contact us at 724.653.1451.