July 2018 Pharmacy Update

FDA VALSARTAN RECALL

As you already may be aware, there was a national FDA recall on valsartan-containing products from several drug manufacturers due to higher-than-acceptable amounts of N-nitrosodimethylamine (NDMA) being found in certain batches. NDMA is considered a possible human carcinogen as it has been found to increase the occurrence of cancer in animal studies.


What YOU need to know:

  • Not all valsartan-containing products are affected and being recalled.
  • FDA list of specific recalled medications and their manufacturers, NDCs, Lot #s, and expiration dates: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM613921.pdf
  • Several prescribers have switched patients to different medications within the same class out of extra precaution. Some cost-effective generic alternatives include: losartan, irbesartan, olmesartan, and candesartan.
  • If you would like additional information, such as a dose comparison chart for ARBs, please feel free to contact the SVHP Clinical Pharmacist via email or phone.
  • As always, health care professionals are encouraged to report any adverse reactions to any medications to the FDA’s MedWatch program: www.fda.gov/medwatch/report.htm

FDA Recommendations for PATIENTS: (from the FDA website)

  • Not all valsartan-containing medications are affected and being recalled.
  • Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.
  • If you are taking any medication containing valsartan, compare the information on your prescription bottle to the recall list to determine if your current medicine has been recalled. If you are not certain, contact your pharmacist.
  • If you have medicine included in the recall, contact your pharmacist. The pharmacist may be able to provide you with valsartan made by another company. If not, contact your doctor immediately to discuss other treatment options.