FDA Investigates Zantac Cancer Risks, Issues Consumer Warning

FDA Investigates Zantac Cancer Risks, Issues Consumer Warning

The United States Food and Drug Administration (FDA) has issued warnings about cancer risks associated with the popular stomach acid medication Zantac. USA Today reports the FDA found unacceptable levels of the probable carcinogen NDMA, or nitrosodimethylamine while testing Zantac and its generic, ranitidine, in September.

Zantac has been routinely used by heartburn sufferers for decades, leading consumers to question how the drug became a potential carcinogen.

Zantac was prescribed more than 15 million times a year without safety concerns prior to the FDA’s announcement. The agency wants manufacturers to test and recall drugs to see if NDMA levels exceed standards. Investigations still seek to determine if Zantac and ranitidine users face greater cancer risk, but the agency said consumers might want to choose different medications. The FDA found no NDMA in over-the-counter alternatives such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec.

How did such a popular over-the-counter drug become a potential cancer risk?

The agency is still working to determine how the carcinogen is formed. FDA officials are testing samples and publishing standards for worldwide regulators and drug manufacturers. Many chemists believe that ranitidine is reacting with something else during manufacturing, finishing, or in storage. The FDA also asked pharmaceutical companies to examine if the drug’s ingredients are exposed to nitrites during manufacturing.

The FDA and independent agencies have conducted studies on ranitidine in the stomach and intestine with inconclusive results. The FDA studied how ranitidine reacts with stomach and intestine fluids and found no evidence that Zantac formed carcinogens. However, Valisure, an independent online laboratory, and pharmacy tested Zantac in stomach-like fluids with added nitrates commonly found in the body and in foods. With nitrates added, Valisure found one tablet of Zantac exceeded the FDA’s NDMA threshold 3,100 times.

Following the agency’s announcement, many retailers and drugmakers took action. Health Canada stopped distributing the drug. Sanofi, a French drugmaker, recalled the drug from retail shelves and drugstores. Germany, Italy, and Switzerland did the same. Taiwan instituted a fine for any pharmacy with ranitidine on its shelves, and Pakistan banned the drug’s distribution and manufacturing.

In the United States, eight companies pulled ranitidine from their shelves. These included pharmaceutical companies and generic ranitidine drugs from Kroger and Walgreens. Despite the voluntary recalls, the FDA took a more measured approach, asking manufacturers to recall the drugs if NDMA exceeds standards after testing.

Zantac was approved for mass markets in 1984, and researchers at Valisure said the drug’s potential risks can be found in medical studies close to its inception. Valisure CEO David Light said the risk appears to be in the drug itself, instead of as a manufacturing byproduct, and that the problem has been there since the 1980s. In a petition to the FDA, Valisure cited the 1987 study on the concerns of ranitidine conducted by Glaxo Research Group, Zantac’s original research group.

The 1987 Glaxo study examined the stomach contents of people who took Zantac. The study found no significant increase in NDMA in users, but Light claimed the study was not accurate. Light said researchers discarded stomach samples that contained ranitidine and used less accurate testing methods. Light said researchers would not find NDMA without those samples.

While researchers and other agencies seek to determine if Zantac contains unsafe levels of NDMA, the FDA extended voluntary recalls to nizatidine, a similar drug sold under the brand name Axid, if testing shows it exceeds NDMA daily limits. NDMA was also the carcinogen that led to the July 2018 recall of valsartan and losartan, two popular blood-pressure-lowering medications.

At this point in investigations, the FDA is not calling for patients to stop taking ranitidine and the agency has not requested a manufacturer recall. Some companies have voluntarily suspended Zantac sales while waiting for results from ongoing tests and research. NDMA is classified as a probable carcinogen, but it does not see that NDMA levels are high enough in Zantac to cause cancer. However, ranitidine is not recommended for long-term use and the FDA suggests patients talk to a health care professional about alternative treatment options.

Share

Litigation Updates

Zantac Lawsuit Update June 2022

May 26, 2022

May 26, 2022

Zantac Lawsuit Update June 2022

Zantac Lawsuit Update May 2022

May 20, 2022

May 20, 2022

Zantac Lawsuit Update May 2022

Zantac Multidistrict Litigation Sets Out For 2023 Bellwether Trials

October 29, 2021

October 29, 2021

Zantac Multidistrict Litigation Sets Out For 2023 Bellwether Trials

Federal Judge Rids Labeling Claims in Zantac MDL

January 11, 2021

January 11, 2021

Federal Judge Rids Labeling Claims in Zantac MDL

Veterans Prescribed Zantac at the VA have Filed Zantac Lawsuits

November 9, 2020

November 9, 2020

Veterans Prescribed Zantac at the VA have Filed Zantac Lawsuits

New Class Action Zantac Lawsuit Includes Claims from More Than 200 Zantac Users

September 16, 2020

September 16, 2020

New Class Action Zantac Lawsuit Includes Claims from More Than 200 Zantac Users

CLIENT REVIEWS

quotation
Tom Lewis

TorHoerman Law was responsible for handling a medical case for our family. I was extremely impressed with their professionalism and ability to react quickly. They also did a nice job keeping us updated with the case throughout the process. This was the first time experiencing a situation like this and Tor Hoerman law did an excellent job from start to finish.

quotation
Jordan Terry

TorHoerman Law is an extraordinary law firm – a firm that truly makes the client’s best interests the primary concern. Their team of personal injury lawyers are experienced, personable, and well versed in a range of litigation areas. They are supported by a dedicated team of staff that are as equally friendly and helpful. I would recommend TorHoerman Law for any personal injury litigation needs.

quotation
Dave Woodley

All of my questions were answered quickly and in a way I could understand. Steve and the entire staff were friendly and professional.

quotation
Jordan Butler

I highly recommend this law firm! The attorneys and staff at THL worked hard, communicated every step of the process, kept me well informed at all times, and exceeded all expectations! The staff is kind, considerate, professional, and very experienced. Look no further, call now!

quotation
Maddy Moeller

Top-notch, hardworking attorneys!

quotation
Karen Hersman

A wonderful and professional legal team. They helped me when I needed expert legal representation! Thank you TorHoerman Law!

THANK YOU FOR YOUR MESSAGE

One of our associates will follow up with you shortly