U.S. Food and Drug Administration (FDA) has announced all manufacturers to halt the production of all variants of ranitidine drugs from the market. It applies to both prescriptions based and over-the-counter (OTC) versions of this drug such as Zantac.
Here is a link to FDA’s official press release.
This announcement was made shortly after the investigation on a contaminant called N-Nitrosodimethylamine (NDMA) which is found in all ranitidine medicines. If you don’t know, ranitidine medications are famous for their brand name called “Zantac”.
FDA has determined that some ranitidine medicines are contaminated with this impurity while it was stored on high temperatures. This temperature is a little higher than the standard room temperature which allows this contamination to take place. This contamination has led to immediate calls out from the market, aiming all Zantac pills to be removed from public access. During this period, no ranitidine products would be recommended to new patients. The existing patients using Zantac are requested to use their alternatives.
Janet Woodcock director at Center for Drug Evaluation and Research by Food and Drug Administration (FDA) says; “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
She further added; “The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,”
N-Nitrosodimethylamine commonly called NDMA is a dangerous substance that could cause cancer in its patients. Food and Drug Administration (FDA) first came to know about NDMA contamination in ranitidine in June 2019, during an independent lab test. Usually, a low amount of NDMA is already present in natural food sources such as seafood. However, it doesn’t cause cancer in humans unless the amount exceeds.
Initial tests confirmed the presence of NDMA in ranitidine but in trace amount only. There was not sufficient data to propose a ban Zantac pills preventing people from taking it. However, a detailed inquiry and investigation confirmed its presence and the possible side effects for human health in September 2019. The investigation reports NDMA presence in both prescription-based and over the counter variants of ranitidine.
Now third-party testing has further confirmed an increase in NDMA levels inside ranitidine during its storage. The amount was even higher in samples stored at a slightly higher temperature and the same product was available for the common public to use.
The report further discussed that NDMA was found in greater quantities in older batches of all ranitidine products. It suggests that its amount increase with time, eventually making it extremely risky for human health.
Today’s announcement by the Food and Drug Administration (FDA) ended with informing all ranitidine manufacturers to withdraw their stock from the market. FDA is also recommending people not to use ranitidine in any form. Those who wish to continue their treatment are advised to consult their doctors and use a safer alternative of Zantac.
There are many other medicines that are approved by the FDA for treating the same problems. Those products are NDMA-free and safe for usage. Some of them are “famotidine (Pepcid)”, “cimetidine (Tagamet)”, “esomeprazole (Nexium)”, “lansoprazole (Prevacid)” and “omeprazole (Prilosec)”.
Note- as the coronavirus pandemic is at the peak, the FDA has recommended all people who are on a daily medication to take special care. It also includes that they should not continue using a drug that has been called out by the FDA for being unsafe such as Zantac. Food and Drug Administration (FDA) advises all people who currently have this medicine in their possession to safely dispose of it at home.