The U.S. Food and Drug Administration announced a recall of a common drug used to treat high blood pressure and heart failure. The medication is said to include an active ingredient that could potentially cause cancer.
After laboratory tests, according to the FDA, the impurity N-nitrosodimethylamine (NDMA) was found in the products, specifically in valsartan, supplied by a third-party. Valsartan is off-patent and commonly used as a component of other generic medicines, but not all drug products containing the ingredient are involved.
NDMA is commonly known as a carcinogen, formerly used to make liquid rocket fuel and antioxidants, but is currently used for research purposes. Symptoms of exposure of NDMA at high levels can include, fever, headaches, nausea, vomiting, jaundice, and can reduce function of the lungs, liver and kidneys.
Patients who are taking the recalled Valsartan should continue taking their medicine until they have a replacement products.
According to the Center for Drug Evaluation and Research, the recall came a week after 22 other countries had recalled the medication. Experts stated the reason why NDMA was in the medication was “thought to be related to changes in the way the active substance was manufactured.” To determine whether a product has been recalled, patient should look at the dug name and company name on the label of their prediction bottle. If the information is not on the bottle, patient should take immediate action and contact their pharmacy that dispenses their medicine to avoid potential cancer risk.
Patients should also contact their health care professional to discuss their treatment if one does use valsartan, so medical professionals can prescribe another valsartan product not affected by the recall. One should also follow all instructions provided by the specific company.
The companies affected were:
- Valsartan by Solco Healthcare
- Major Pharmaceuticals
- Teva Pharmaceuticals Industries Ltd
- Valsartan/Hydrochlorothiazide (HCTZ) by Teva Pharmaceuticals
- Solco Healthcare
According to CNN, around 2,300 batches were involved in the early recall, including Finland, Germany, Sweden, Norway, the Netherlands, Hungary, Austria, Italy, Ireland, Bulgaria, Belgium, Spain, Portugal, Croatia, France, Poland, And, Lithuania, Greece Herzegovina, Bosnia, Malta, and Bahrain.
For more information about what to do with the recalled products, you can visit the FDA website, here.