On July 13, 2018, The U.S. Food and Drug Administration (FDA) announced a voluntary recall of certain medications containing valsartan. Valsartan is the active ingredient in some drugs used to treat high blood pressure and heart failure. Valsartan supplied to the drug manufacturers, by a specific third-party, has been found to be contaminated with N-nitrosodimethylamine (NDMA) which may cause cancer in humans. The FDA did not name the supplier of the contaminated ingredient but did give a list of the potentially contaminated drugs which have been recalled.
Recalled Heart Medications
Not all medications containing valsartan have been recalled. Those which have been are generic versions made by certain companies. The medications listed in the recall notice are:
- Valsartan – Major Pharmaceuticals
- Valsartan – Solco Healthcare
- Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare
- Valsartan – Teva Pharmaceuticals Industries Ltd.
- Valsartan/Hydrochlorothiazide (HCTZ) – Teva Pharmaceuticals Industries Ltd.
What Went Wrong with the Recalled Valsartan?
NDMA was found in the recalled products. The FDA says it believes that the contamination was a result of changes in the way the affected valsartan was manufactured. NDMA is classified as a probable human carcinogen, by the World Health Organization (WHO). According to the U.S. Environmental Protection Agency (EPA), exposure to high levels of NDMA may cause liver damage.
Recalls in Europe and Asia
In June 2018, several heart drugs containing valsartan were recalled in Europe and Asia after Zhejiang Huahai Pharmaceutical, a Chinese valsartan supplier, found NDMA residues in its supplies.
If you believe that you may have been harmed by taking contaminated heart medication, please talk to an experienced pharmaceutical injury attorney right away to learn more about your rights and potential compensation.