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April 09, 2020

FDA Recommendations Regarding (OTC) Ranitidine Drugs

On April 1, 2020, the FDA announced a voluntary recall of ALL prescription and over-the-counter (OTC) ranitidine products for an ongoing investigation of an impurity¬†(N-nitrosodimethylamine “NDMA”). NDMA is considered a probable carcinogen by the International Agency for Research on Cancer.

Dispensing retail pharmacies will contact patients whose prescriptions are affected. Your patients may contact you because they learn about the recall for their prescribed or OTC product and ask for a recommendation for an alternative medication.

Recommendation:

  1. Inform patients to STOP taking any OTC or prescription ranitidine products
  2. For those who need alternative histamine-2 blockers (H2RA) agents, recommend alternatives that do NOT care the same risks from NDMA. To date, the FDA’s testing has not found NDMA in:
    • Famotidine (Pepcid)
    • Cimetidine (Tagamet) – please note that cimetidine may interact with other drugs and drug-drug interactions must be checked

If your clinic feels appropriate to contact patients possibly affected, there is the option for providers to generate EPIC reports to identify your patients on certain medications.

Recall Links:

https://www.fda.gov/safety/medical-product-safety-information/all-ranitidine-products-zantac-press-release-fda-requests-removal

Ranitidine Dosage Conversion Table

Ranitidine

Famotidine (preferred alternative)

Cimetidine

150 mg daily

20 mg daily

400 mg daily

150 mg twice daily

20 mg twice daily

400 mg twice daily

300 mg daily at bedtime

40 mg daily at bedtime

800 mg daily at bedtime

150 mg four times daily

40 mg twice daily

1600 mg twice daily


MyHealth Smart Phrase Bulk Patient Message Example

Dear @PATIENTNAME@,

Your records indicate that you are currently taking Ranitidine, also known as Zantac, which is available as prescription and over-the-counter.

On April 1, 2020, the FDA announced a voluntary recall of ALL ranitidine products for an ongoing investigation of an impurity (N-nitrosodimethylamine “NDMA”). The FDA did not observe any unacceptable levels of NDMA in any tested ranitidine samples, but are being proactive and cautious with the voluntary recall of all ranitidine products. The FDA does not expect NDMA to cause harm when ingested at low levels.

For more information on this recall, please refer to: https://www.fda.gov/safety/medical-product-safety-information/all-ranitidine-products-zantac-press-release-fda-requests-removal

Your Stanford primary care physician recommends that you STOP taking ranitidine. Should you need a replacement, you can substitute with an alternative that does NOT carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine, also known as Pepcid (available over-the-counter).

If you are taking:

  • Ranitidine 150mg daily, you can switch to famotidine 20mg daily
  • Ranitidine 150mg twice daily, you can switch to famotidine 20mg twice daily
  • Ranitidine 300mg daily, you can switch to famotidine 40mg daily

If you cannot take or tolerate famotidine (Pepcid) or have additional questions, please contact your primary care provider.