Ranitidine - FDA requests removal of all products from the market

FDA announcement on all Prescription and Over-the-Counter (OTC) Ranitidine products

On April 1, 2020, the FDA announced that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. The FDA said it had determined that NDMA in some ranitidine products increases over time and when stored at higher than room temperatures, resulting in consumer exposure to unacceptable levels of the impurity.

https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

What do I need to know?

• Express Scripts will be sending letters to impacted patients.
• The FDA is advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products
• Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.
• To date, the FDA’s testing has not found NDMA in Famotidine (Pepcid), Cimetidine (Tagamet), Esomeprazole (Nexium), Lansoprazole (Prevacid) or Omeprazole (Prilosec).

• In light of the COVID-19 pandemic, the FDA recommends that you do not take your withdrawn medication to a drug take-back location, but instead you can safely dispose of the unused medication in your household trash by doing the following:

  1. Mix the pills/liquid with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
  2. Place the mixture in a container such as a sealed plastic bag.
  3. Throw away the container in your trash at home.
  4. Remove or delete all personal information on the prescription labels of empty medication bottles or packaging, then throw them away or recycle them.

Why is this medication being removed from the market?

• This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.
• Any suspected adverse events that may be related to the use of these products should be reported to your doctor. You can also report adverse events that may be related to this recall to FDA's Med Watch Program either online, by regular mail or by fax.
• Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
• Regular Mail: Use postage-paid, pre-addressed Form FDA 3500B available at: https://www.fda.gov/media/85598/download. Mail to the address on the pre-addressed form.
• Fax: 1-800-332-0178 (toll free)