The News:
On April 1, 2020 the Food and Drug Administration (FDA) announced their request for all over-the-counter and prescription ranitidine products to be removed from the market.
Background:
Since the summer of 2019, the FDA has been conducting an ongoing investigation of ranitidine products due to the presence of a chemical impurity. Ranitidine (also known by its brand name, Zantac) is a commonly used medication to treat heartburn and has traditionally been available both over-the-counter and by prescription. The chemical impurity being studied is a contaminant called N-nitrosodimethylamine (NDMA).
NDMA is a potential human carcinogen, which means that it could cause cancer when ingested in certain amounts. Initially, NDMA was found in ranitidine products in very low levels through independent laboratory testing. Small amounts of NDMA are also known to be found in many foods and water sources. Thus, we may regularly consume NDMA in our diets, but these levels are so low that they are not thought to be harmful or lead to cancer. However, at higher levels and over a longer period of time, NDMA may increase cancer risk.
When the investigation began, the amount of NDMA being found in ranitidine products was so small that the FDA did not have enough information to support telling patients to stop taking the medication. This was a decision left up to the patient and physician. However, with further testing, the FDA has confirmed that the levels of NDMA increase over time after the medication is manufactured. Levels of NDMA also increase when the medication is stored at higher temperatures. Because these increased levels may not be appropriate for daily consumption, the FDA issued their request for market removal of ranitidine to ensure our safety.
What You Should Do:
The FDA is recommending that all patients taking over-the-counter ranitidine dispose of their current supply and switch to an alternative product. If you are taking a prescription ranitidine product, discuss alternative options with your doctor before stopping the medication. There are several alternatives to ranitidine available both over-the-counter and with a prescription, including famotidine (Pepcid), omeprazole (Prilosec), esomeprazole (Nexium), and lansoprazole (Prevacid).
Of note, during the current COVID-19 outbreak, the FDA recommends in-home disposal of your medication rather than travelling to a medication take-back location. To dispose of your ranitidine at home, you may empty the medication into a plastic bag, mix it with an unappealing substance such as kitty litter or used coffee grounds, seal the bag, and discard it in your household trash. You may also use a sealable container such as an empty milk carton or laundry detergent bottle.
How Sona is Helping:
Here at Sona, your health and safety is always our number one priority. Throughout the coming week, we will be doing our best to contact physician’s offices on behalf of our patients currently taking ranitidine in order to get them switched to an alternative medication. If you are interested in purchasing an alternative to ranitidine over-the-counter, one of our pharmacists will be glad to assist in finding the best option for you. As we are encouraging our patients to utilize our drive-thru service at this time if able, and please know that we would love to “shop” the shelves for you! And as always, we are happy to deliver any prescription or over-the-counter items you may need. Please do not hesitate to call us at 828-298-3636 if we can help to serve you in any way. Our goal is to make this medication transition as smooth as possible!
