Zantac to be removed from market due to contamination

April 2, 2020 in Disease Management  •  By Miles Varn, MD

If you take Zantac (ranitidine) or a generic version of this medication, the Food and Drug Administration (FDA) recently announced that you should stop taking any form of the drug and dispose of it properly. The reason for this recommendation is that all ranitidine products are currently being investigated by the FDA related to contamination with a substance called as N-Nitrosodimethylamine (NDMA), which is a probable human carcinogen (a substance that could cause cancer).

During its investigation, the FDA has found that this impurity increases over time when the medication is stored at higher than room temperature, which can happen when the medication is stored in a bathroom cabinet. This increase may result in people being exposed to what the FDA deems to be unacceptable levels of the impurity.

Because of this, the FDA has asked for all forms of ranitidine, both over-the-counter and prescription, to be removed from the market in the U.S. In fact, many stores had already pulled over-the-counter versions of the medication from shelves when the presence of this impurity first came to light late last year.

If you were taking ranitidine to treat or prevent ulcers or gastroesophageal reflux, talk with your primary care doctor or gastroenterologist to find out what other medications you can switch to. If you are taking a prescription form of the drug, talk with your doctor before stopping your medication. To date, the FDA has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec), all of which can be used to treat these conditions.

How to safely dispose of the medication

Because of the COVID-19 pandemic, the FDA does not recommend that you dispose of your ranitidine at a drug take back site, like a pharmacy, where you could be exposed to people who have the virus. Instead, you can follow the FDA’s recommended home disposal process:

  • Remove the medication from its original packaging and mix it with something undesirable like coffee grounds or used kitty litter.
  • Put the mixture in a sealable container like a zipper storage bag or can or container with a lid.
  • Throw the container in the garbage.
  • If the medication was prescribed by a doctor, protect your privacy and identity by scratching out all personal information on the bottle (name, address, etc.), then throw the bottle in the trash.

What to do if you’ve experienced adverse events or side effects from ranitidine

If you experience an unexpected medical problem, also called an adverse event, or side effect from these medications, the FDA encourages you or your doctor to report the problem to the MedWatch Safety Information and Adverse Event Reporting Program.

You can report the problem online or call 1-800-332-1088 to request a form, then complete and return it to the address on the form, or submit it by fax to 1-800-FDA-0178.