Zantac™ is Back: Same Brand, A Familiar but Different Ingredient

Zantac™ is Back: Same Brand, A Familiar but Different Ingredient
Bobby LeDuff, PharmD, Essentia Health

All products of ranitidine were recalled by the Food and Drug Administration (FDA) in April 2020 due to alarming amounts of N-Nitrosodimethylamine (NDMA) found in prescription and over the counter formulations. According to the FDA, NDMA is commonly ingested at low levels through water and certain foods; moreover, ingestion of NDMA at low levels is considered to be safe. According to Lim et al., NDMA is classified as a probable human carcinogen when people are exposed to sustained higher levels. Initial laboratory testing of ranitidine found low levels of NDMA, but clinicians found that these levels increased over time beyond the acceptable daily intake limit, even under normal storage conditions. With these discoveries, all ranitidine products are likely to remain off the market for the foreseeable future.

After more than a year of being off the market, Zantac™ is coming back to the market but with a new active ingredient, famotidine. Zantac™ will now be marketed as Zantac 360°™ Original Strength, which will be famotidine 10 mg, and Zantac 360°™ Maximum Strength, which will be famotidine 20 mg. It is important to note that the “360” in the rebranding has nothing to do with the quantity, dosing, or strength of the product and may lead to patient and prescriber confusion. Some ways to prevent confusion are to use both brand and generic name when referring to the product and review patient charts and medication lists for duplicate therapy. The rerelease of Zantac 360°™ will be an interesting experience for pharmacists to say the least.

 

Reference:

  1. FDA requests removal of all ranitidine products (zantac) from the market. U.S. Food and Drug Administration.https://www.fda.gov/news-events/press-announcements/fda-requests-removal.... Published April 1, 2020. Accessed August 9, 2021.
  2. Lim HH, Oh YS, Shin HS. Determination of N-nitrosodimethylamine and N-nitrosomethylethylamine in drug substances and products of sartans, metformin and ranitidine by precipitation and solid phase extraction and gas chromatography–tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis. 2020;189:113460. doi:10.1016/J.JPBA.2020.113460 Published July 4, 2020. Accessed August 9, 2021.
  3. Watch for unexpected ingredients in new zantac products. Pharmacist's Letter. https://pharmacist.therapeuticresearch.com/Content/Articles/PL/2021/Jul/.... Published July 2021. Accessed August 9, 2021.