Why Was Zantac (Ranitidine) Recalled by the FDA?

It was no April Fool’s Day joke when the U.S. Food & Drug Administration (FDA) issued a news release requiring the recall of every single ranitidine drug on the market.

Ranitidine, commonly known as Zantac, an over-the-counter (OTC) heartburn medication taken by an estimated 15 million Americans, had been found to contain an unacceptable level of a contaminant called N-Nitrosodimethylamine (NDMA.) NDMA actually is much more than a contaminant – it also is a carcinogen, meaning it can cause cancer.

“The FDA is committed to ensuring that the medicines Americans take are safe and effective,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said in the April 1, 2020 news release, titled “FDA Requests Removal of All Ranitidine Products (Zantac) from the Market.” “We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science.”

NDMA Explained

NDMA – in extremely small amounts – is present in food and water and commonly ingested through the everyday diet. It is not a cancer causer in such a situation. NDMA in ranitidine – first reported in September 2019 following tests conducted by an independent laboratory – were detected at relatively low levels initially; however, the FDA learned that NDMA in ranitidine increases over time and in higher-than-room-temperature spaces.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” Dr. Woodstock said. “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. 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.”

14 manufacturers have pulled their pills from store shelves:

• American Health Packaging, Amneal Pharmaceuticals
• Apotex, Appco Pharma, Aurobindo Pharma USA
• Denton Pharma (dba Northwind Pharmaceuticals)
• Reddy’s Laboratories, Glenmark Pharmaceuticals
• Golden State Medical Supply
• Lannett, Novitium Pharma, Perrigo
• Precision Dose

Sandoz.

“With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market,” according to the news release. “The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

“In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home,” the news release continues. “The FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.”

Potential Injuries

NDMA is linked to bladder cancer, colorectal cancer, gastric cancer, pancreatic cancer and stomach cancer and tumors in the kidneys, liver and lungs. Consumers exposed to NDMA could experience additional symptoms including abdominal cramps, dizziness, fever, headaches, jaundice, nausea and vomiting. Other adverse events associated with NDMA are arrhythmia (irregular heartbeat) and tachycardia (rapid heartbeat), hair loss and skin rashes, nervous-system disorders and vitamin-B12 deficiencies.

“If you’ve been relying on a drug with ranitidine to deal with heartburn for who knows how long, try to remember that the chances you’ll develop cancer because of this are overall extremely low,” states a Self article titled “Update: The FDA Wants Zantac Off Shelves Because of a Possibly Carcinogenic Impurity.” “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods…. With that said, you should get in touch with your doctor for an evaluation if you experience any strange symptoms that concern you. Anything like unintentional weight loss, bloody or tarry stools (which may indicate intestinal bleeding), symptoms of anemia like fatigue and weakness, or new abdominal pain out of proportion to what you experience on a regular basis is worth bringing up with a doctor. If you have any additional cancer risk factors (like a history of smoking) and are really worried, it can be smart to talk to your doctor about your health as well. The same goes if you decide to switch treatment and your heartburn persists or worsens.”

Zantac Lawsuits

Some manufacturers of Zantac now are being hit with class-action lawsuits on behalf of plaintiffs who claim the companies knew of the presence of NDMA in the medication yet did not disclose that information to the FDA. Further, the United States Judicial Panel on Multidistrict Litigation (MDL) established a Zantac MDL in the United States District Court’s Southern District of Florida, meaning that all federally filed Zantac lawsuits will be consolidated there.

Searcy Denney Scarola Barnhart & Shipley is investigating cases on behalf of clients who took Zantac and have been diagnosed with cancer or other diseases and / or conditions. If you or a loved one is experiencing serious symptoms because of taking Zantac, you could be entitled to compensation from the manufacturers for:

Past and future medical expenses resulting from injuries

Past and future pain and suffering resulting from injuries

Past and future wage reduction

Past and future loss of enjoyment of life

Possible punitive damages

For more information, please contact our office for a free legal consultation.