FDA issues new drug safety guidelines following Zantac, ranitidine recall

A package of the over-the-counter version of Zantac sits on a pharmacy shelf.

The Food and Drug Administration recently published guidance for drugmakers on how to limit the amount of cancer-causing chemicals known as nitrosamines in medications. The FDA’s new guidelines were issued in response to the widespread contamination of the heartburn drug Zantac (ranitidine) with N-nitrosodimethylamine (NDMA), a type of nitrosamine.

NDMA and other nitrosamines are found in the air, water, and food in small doses that are normally harmless. However, when individuals are exposed to higher doses of these chemicals — such as the amounts that were detected in Zantac — they can cause cancer.

Zantac Contamination Leads to Concerns About Nitrosamines

The FDA’s concerns about the contamination of prescription medications with nitrosamines was prompted by reports in Fall 2019 that Zantac and generic ranitidine were contaminated with NDMA.

These reports prompted the FDA to conduct an investigation, which found that when these heartburn drugs were stored at room temperature, they could become contaminated with NDMA over time. Patients who were treated with Zantac or ranitidine that is contaminated with NDMA may face an increased risk of being diagnosed with cancer.

The FDA’s investigation found that all of the Zantac and ranitidine products that it tested had become contaminated with NDMA after only two weeks of storage. Scientists who conducted the investigation concluded that the level of contamination with NDMA would increase the longer Zantac and ranitidine were stored on shelves.

FDA Orders Zantac, Ranitidine Recall Due to Increased Cancer Risks

After the FDA’s investigation concluded that Zantac and ranitidine were significantly contaminated with NDMA, the agency ordered drugmakers to recall the two heartburn drugs because they could expose patients to an increased cancer risk.

Generic versions of ranitidine were recalled by Sandoz, a division of Novartis AG, in September 2019; GlaxoSmithKline announced that it would recall the prescription version of Zantac the following month. Around this same time, several nationwide pharmacy chains — including CVS, Walmart, Walgreens, and Rite Aid — announced that they would stop selling brand name versions of Zantac as well as generic versions of ranitidine.

FDA Guidance on NDMA, Nitrosamines in Medications

The new FDA guidance identifies several conditions under which nitrosamines can form in medications. Some of these conditions include the improper purification of prescription drugs, poor quality control measures, chemical reactions, and contamination from raw materials that are used in the manufacturing process.

The FDA guidance also sets limits for the amount of nitrosamines that can be permitted in prescription medications without exposing patients to a significantly increased cancer risk. For NDMA, the chemical that was found in Zantac and generic ranitidine, the limit is 96 nanograms (ng) per day (based on the daily recommended dose of the drug).

However, the FDA also advised drugmakers that these limits only apply when a single nitrosamine contaminant is found in the medication. In cases where more than one nitrosamine is discovered, or where the total quantity of nitrosamines is higher than 26.5 ng/day with a maximum daily dose, drugmakers are instructed to contact the FDA so that the agency can evaluate.

Lawsuits Filed by Zantac, Ranitidine Users with Cancer

In the months following the Zantac and ranitidine recalls, hundreds of patients who were diagnosed with cancer after using these medications filed lawsuits against the pharmaceutical companies who made these products and the pharmacies that sold them to patients.

As of October 2020, there are 500 federal Zantac lawsuits that have been filed in Florida federal court. These lawsuits accuse the manufacturers of Zantac and ranitidine of failing to ensure the safety of their products and of failing to warn patients about the increased risk of cancer they could face from using these medications.

Contact An Attorney for a Free Legal Consultation

If you or a loved one used prescription or over-the-counter versions of Zantac or ranitidine and have been diagnosed with cancer, you may be eligible to file a lawsuit. The first step in filing a claim is to talk with an experienced pharmaceutical liability attorney, who can advise you regarding your legal rights and walk you through the initial steps in taking legal action.

For more information about filing a Zantac or ranitidine lawsuit and to find out whether you qualify to file a claim, contact the lawyers at Hissey, Mulderig & Friend to schedule your free legal consultation. You can reach us by calling toll-free at 1-866-806-8117, or by completing our free case evaluation form located on the right side of this page. After we receive your message, a member of our staff will contact you for additional information and to schedule your free consultation with one of our lawyers.

About the Author: Hissey, Mulderig & Friend