FAQs for Valsartan Recall

July 30, 2018

FAQs for Valsartan Recall

FAQs for Valsartan Recall                                

Q: Where all products containing valsartan affected?

A: No.  Below are the effected products and companies:

Valsartan - Major Pharmaceuticals

Valsartan - Solco Healthcare

Valsartan - Teva Pharmaceuticals Industries Ltd.

Valsartan/Hydrochlorothiazide (HCTZ) - Solco Healthcare

Valsartan/Hydrochlorothiazide (HCTZ) - Teva Pharmaceuticals Industries Ltd.

FDA continues to evaluate valsartan-containing products and maintains a list of products included in the recall and the list of products excluded from the recall.

Q: How do I know if my patients are affected?

A: You do not.  Many pharmacies carry many different manufacturers of the same medication.  Please advise your patient to call their pharmacy to find out if they have the recalled medication in their possession.

Q: Should I change my patient to a different angiotensin receptor blocker (ARB?)

A: Although this is not a recall of the active ingredient valsartan, it is a recall of the drugs containing valsartan that were tainted during manufacturing process with NDMA.             

This recall may lead to short supplies of valsartan from other manufacturers, and it may be prudent to consider changing your patient to another ARB, such as:  candesartan, irbesartan, losartan, olmesartan, or telmisartan.

Q: If my patient is taking one of the affected valsartan products, is there a risk of cancer?

A: The Environmental Protection Agency (EPA) considers N-nitrosodimethylamine (NDMA) to be a group B2 agent.  “Group B2 is used for agents that have sufficient animal studies, but inadequate or no data from epidemiologic studies.”

NDMA has been found in foods, such as smoked or cured meats, malt beverages such as beer and whiskey, drugs, and tobacco smoke.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf

https://a816-healthpsi.nyc.gov/ll37/pdf/carcclassJuly2004_1.pdf

For additional information please call 1-844-769-5879