On Wednesday, January 2, 2018, Aurobindo Pharma USA, Inc. joined Teva Pharmaceuticals, Solco Healthcare, and Northwind Pharmaceuticals, among others, becoming the latest drug manufacturer to voluntarily recall its blood pressure medication valsartan due to concerns that the tablets might contain a trace amount of a cancer-causing substance. Valsartan is a common ingredient used in drugs that treat high blood pressure and help prevent heart failure.
Aurobindo Pharma USA, Inc., based out of New Jersey, will be recalling 80 lots of the company’s valsartan-containing tablets. Valsartan is the same blood-pressure medication ingredient that has been under FDA scrutiny for the past 6 months, starting in July 2018 when the first batches of valsartan were recalled over concerns of contamination by N-nitrosodiethylamine (NDEA), a likely human carcinogen.
The Aurobindo Pharma USA, Inc. recall includes:
- Amlodipine Valsartan tablets USP
- Valsartan HCTZ tablets
- USP and Valsartan Tablets USP
Label images for any effected medications can be found on the Food and Drug Administration’s (FDA) recall announcement.
Is Valsartan Safe?
Any drug that contains an impurity can be very dangerous, and valsartan is no different. NDEA is an organic substance that is sometimes found in air pollution and the byproducts of certain industrial processes, including the manufacturing of pesticides. NDEA is also found in liquid rocket fuel.
According to the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC), NDEA has been classified as a probable human carcinogen, meaning continued exposure to it could lead to cancer. In research conducted by the Environmental Protection Agency (EPA), people exposed to low levels of NDEA experienced a range of adverse health effects, including:
- Liver damage
- Nausea and vomiting
- Abdominal cramps
- Headaches and fever
- Lowered platelet counts
In animal testing, severe liver damage was detected, as well as an increase in liver and kidney tumors and other types of tumors throughout the body.
Should You Stop Taking Valsartan?
At this time, Aurobindo Pharma USA, Inc. has not received any adverse health reports regarding its valsartan medications. The FDA recommends to patients taking a valsartan-based medication that they continue taking their medication until they have discussed with their pharmacist or prescribing doctor a suitable alternative medication or therapy.
It is important to note that throughout all of the valsartan recalls over the last 6 months, the FDA has continued to stress the importance of not stopping use of the drug without first consulting a medical professional, as stopping use of valsartan-based medication altogether could be even riskier and more harmful than continuing use.
If you are currently taking a valsartan-based medication, or if you think that your medication may contain valsartan, be sure to check your prescription drug bottle for a list of active ingredients and the name of the drug manufacturer. Patients who have any questions about their valsartan medications are encouraged to contact Aurobindo Pharma USA, Inc. directly by phone, at 1-866-850-2876, or via email at [email protected].
As always, any adverse reactions to valsartan should be reported to the FDA’s MedWatch Adverse Event Reporting program. The MedWatch program is designed to keep the quality of the drugs and devices that Americans take and use at the highest level possible. Only through reporting and action—both regulatory and legal—can we keep dangerous drugs and devices out of the hands of vulnerable citizens.