A few months ago, specifically in the summer of 2019, the U.S. Food and Drug Administration (FDA) became aware of laboratory testing that found low levels of NDMA in ranitidine, the generic name of what is commonly known as Zantac. But what is NDMA? NDMA stands for N-Nitrosodimethylamine and it is a contaminant and possible human carcinogen (a substance that could cause cancer), that we actually ingest in certain foods and even water. At low levels, it is not expected to lead to an increase in the risk of cancer yet at sustained levels of exposure it may increase the risk of cancer in humans.
The agency did not have enough scientific evidence to provide to the public and recommend whether to stop or not the use of ranitidine medications so instead, they warned the public in September 2019. New testing has confirmed that NDMA levels do increase in ranitidine even at room temperature and significantly increase in samples stored at higher than room temperature. This becomes a concern during the process of handling and distribution since there is always a likelihood that the products become exposed to high temperatures depending on the location or time of the year. Testing also proved that the older the product is, the greater the level of NDMA. That is specifically the reason why the FDA decided to announce today the request to withdraw all prescription and over-the-counter (OTC) ranitidine medications from the market immediately.
As part of the strategies that are currently being implemented as of today, the FDA is sending letters to all manufacturers of this medication requesting they withdraw their products from the market. In addition, consumers are being advised to stop taking any dosage form of ranitidine at home. Patients being prescribed this medication should speak with their primary care provider about potential treatment options before stopping the medication. There are multiple drugs that are FDA- approved for the same or similar indications that do not carry the same risk (already tested by the FDA) and these are: famotidine (Pepcid), esomeprazole (Nexium), lansoprazole (Prevacid) omeprazole (Prilosec) or cimetidine (Tagamet).
We all know the world is overwhelmed with the COVID-19 crisis and it is definitely not recommended to visit pharmacies at this time to dispose medications. This is why it is very important to follow the instructions in the medication guide or package insert to safely dispose these medications at home. The FDA also recommends a series of steps to safely dispose your medications at home and to make it easier for you guys, here’s the attached link.
Reference
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market [news release]. FDA; April 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market. Accessed April 1, 2020.
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