Update on NDMA Levels in Recalled Valsartan Products
July 27, 2018 – Following a recall of certain valsartan-containing medications, the U.S. FDA has issued a communication regarding the amount of impurity found in affected products. These products, which all contained an active ingredient sourced from Zhejiang Huahai Pharmaceuticals, may have been contaminated with N-nitrosodimethylamine (NDMA).
NDMA is considered to be a probable human carcinogen (cancer-causing agent). This classification is based on animal trials in which much higher doses of NDMA were administered than the amount found in recalled valsartan products. A person can consume an estimated 96 nanograms of valsartan per day without significantly raising their risk of cancer. Small amounts of NDMA can be found in water supplies and some foods.
An estimated one additional case of cancer may occur for every 8,000 individuals due to the NDMA impurity in affected valsartan products, assuming each individual took the highest dose of valsartan (320mg) every day for four years. By comparison, less than one additional case of cancer may occur in every 100,000 individuals under current safety guidelines for NDMA exposure.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.