After months of investigating ranitidine products for the presence of a known human carcinogen, the U.S. Food and Drug Administration (FDA) is now calling for complete removal of all products containing ranitidine from the market. In January 2020, we wrote about the Zantac recall and worries about contamination with N-Nitrosodimethylamine (NDMA) – a contaminant that may cause cancer. Antacid recalls increased toward the end of 2019, but now the FDA is taking the situation a step further.
Why is the FDA Calling for Removal of Ranitidine?
According to the FDA News Release, the FDA is calling for removal of all over-the-counter (OTC) and prescription ranitidine products. The FDA reports that NDMA in some samples increased over time, especially when stored at temperatures higher than “room temperature.” As a result, consumers may consume more than the acceptable daily limit of NDMA. This could, consequently, increase the risk of certain cancers.
Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D., says,
“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.”
New testing and evaluation methods confirm that NDMA levels do increase in ranitidine and Zantac, even under normal storage conditions. In conditions where the temperature is higher than average room temperature, NDMA levels increase significantly. This is concerning since temperatures in storage and distribution areas are often much higher than average room temperature. It is also concerning because the FDA does not know how long certain batches may have been exposed to higher temperatures.
The FDA is sending letters to all manufacturers of ranitidine products requesting immediate withdrawal of products from the market.
What Consumers Need to Know about the Zantac Recall and Removal
If you routinely take Zantac or ranitidine products, you may have already had to change your medication. Many prescription versions of ranitidine have been recalled, and most retailers have stopped selling Zantac and generic ranitidine. Many consumers were hopeful that Zantac would undergo redevelopment and would return to the market once the FDA concluded their investigation.
Instead, the FDA urges consumers to stop using Zantac and ranitidine immediately. The FDA urges consumers to properly dispose of these products, and to refrain from buying more. Instead of using a drug take-back program, the FDA says consumers should follow their safe disposal instructions.
If the medication is on the “flush list” you can flush it down the toilet. Ranitidine is not on the flush list, so consumers should follow the following directions:
- Mix the medication with something that is unappealing, such as coffee grounds, cat litter or dirt.
- Place the mixture in a sealed container or plastic bag.
- Throw the container away in your trash can.
- Remove all personal information from medication bottles.
- Recycle the bottle if possible, or throw it away.
After disposal, consumers who take Zantac or ranitidine regularly should talk to their healthcare provider about other FDA-approved antacids. Products like Pepcid, Prilosec and Nexium are generally suitable alternatives. The FDA reports that none of these medications test positive for NDMA.
How to Report an Adverse Event
While the FDA continues to evaluate the previous Zantac recall and monitor manufacturer efforts to remove products from the market, consumers are urged to report any adverse events that they experience. Consumers can fill out an adverse event report with the FDA through their MedWatch Adverse Event Reporting program.
If you have concerns about your health and your experience with Zantac or ranitidine, you should also talk to your healthcare provider as soon as possible. Your healthcare provider can offer you the best advice on how to control the symptoms of heartburn, acid reflux or other disorders that often benefit from Zantac or ranitidine.
Contact a Zantac Recall Lawyer
Manufacturers of medications and medical devices have a responsibility to ensure that their products are safe for consumers. If you have suffered adversely due to Zantac or ranitidine products, you may be wondering what to do next. Your first step is filing a report with the FDA. Next, you may find it helpful to contact a Zantac recall lawyer.
As a consumer, you have certain legal rights, including the right to take legal action against a manufacturer whose product causes you harm. At Drug and Device Watch, we can review your situation and help you determine if you have an actionable claim. We can answer your Zantac questions and help you understand your legal rights and any options you may have to take legal action.
To request a free consultation with one of our lawyers, call us at 1-888-458-6825. You can also request a consultation through our online form.