We are taking the threat of COVID-19 very seriously. Click here to find out what our firm is doing.
Law Office of Cohen & Jaffe, LLP

FDA Requests Removal of All Ranitidine Products (Zantac )

On April 1, 2020, the United States Food and Drug Administration (FDA) requested the removal of all over-the-counter and prescription ranitidine medications from the market. This announcement marks the most recent development in an investigation involving n-nitrosodimethylamine (NDMA), which is found in ranitidine medications including Zantac.

This decision comes after the FDA determined that the impurity in ranitidine products increases over time when the medication is stored in locations with high temperatures. Due to this immediate request to withdraw the medication, the medication is no longer available for new or existing prescriptions or over-the-counter usage.

Statement by the FDA About the Zantac Removal

The FDA has expressed the perspective that it is committed to making sure that the American take is both effective and safe. To make sure that the medication satisfies these requirements, the FDA investigates health risks and provides recommendations to the public based on the available science.

Because quality levels of ranitidine (Zantac) are impossible to determine, the FDA has stated that all versions of the medication should immediately be withdrawn. The FDA also stated that it will continue to review impurities in other medications that do not meet acceptable limits.

The Danger of NDMA

NDMA is a likely cause of cancer in humans. In 2019, the FDA learned of testing that located NDMA in ranitidine. While low levels of NDMA are often ingested as part of a person’s diet, higher levels of exposure to the substance might increase the chance of cancer in humans. The FDA performed laboratory tests and determined that NDMA exists in ranitidine at low levels, but in 2019 the agency did not have enough scientific evidence to determine whether individuals should stop taking the medication.
Later in September 2019, the FDA warned the public of the potential risks presented by the medication. Subsequent FDA testing and evaluations performed by third party laboratories later confirmed that NDMA levels in ranitidine increase even if the medication is stored under normal conditions although NDMA quantities increase substantially in samples stored at higher temperatures. This testing also discovered that the older ranitidine products are, the greater the levels of NDMA.

The Aftermath of the FDA’s Removal Request

Following the FDA’s announcement, the agency sent letters to all ranitidine manufacturers with the requests that they withdraw all of these products from the market. The FDA also advises consumers who currently over-the-counter ranitidine to stop doing so. Before stopping prescription versions of the medication, patients are advised to speak to their healthcare professionals.

The FDA also stated that it has not currently found NDMA in cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid) , or omeprazole (Prilosec). Due to the current COVID-19 pandemic, however, the FDA warns consumers and patients to not take the medicines to drug take-back locations.

Schedule Your Free Consultation With Our Injury Lawyers

If you or a loved one has been harmed by Ranitidine found in any medication including Zantac, speak with our personal injury attorneys regarding a potential zantac cancer lawsuit. Contact us 24/7 to discuss your legal options.

Do not stop taking Zantac without talking to your healthcare professional.

Subscribe to Our Newsletter

Trusted & Respected