Navigate the Valsartan Recall

The valsartan recall will continue to raise questions about how to switch to a different ARB or an ACE inhibitor.

The recalled products may have been contaminated with the probable carcinogen N-nitrosodimethylamine (NDMA) for as long as 4 years...possibly because of changes in how valsartan was made.

Reassure patients that cancer risk is very low. You can point out that FDA estimates 8,000 patients would need to take the recalled valsartan 320 mg daily for 4 years to possibly lead to one additional lifetime diagnosis of cancer.

But don't be surprised if valsartan falls out of favor...especially with shortages and rising prices for the products that are NOT recalled.

Help patients switch to or start an alternate med if needed.

Recommend switching most patients to a generic, low-cost ARB. For example, suggest switching valsartan 80 mg/day to losartan 50 mg/day...or valsartan 160 mg/day to losartan 100 mg/day. Losartan costs under $10/mo.

Also consider an ACEI. For example, lisinopril 20 mg/day lowers BP about the same as valsartan 160 mg/day...and can cost less than $4/mo.

But stick with an ARB for patients who can't tolerate an ACEI due to cough or mild angioedema.

Advise patients to monitor BP more closely if they switch meds.

Use our chart, Comparison of Angiotensin Receptor Blockers, to help with switches based on indication, cost, etc...and our charts, ARB Dose Comparison and ACEI Dose Comparison, for antihypertensive conversions.

Key References

  • www.fda.gov/Drugs/DrugSafety/ucm613916.htm
  • www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf
  • Mayo Clin Proc 2016;91(1):51-60
Pharmacist's Letter. Sep 2018, No. 340901

Medication pricing by Elsevier, accessed Aug 2018



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