On April 1, 2020, the U.S. Food and Drug Administration (FDA) asked manufacturers to withdraw Zantac and other ranitidine drugs from the market immediately.
According to CNN:
“levels of a contaminant in the heartburn medications increase over time and when stored at higher-than-normal temperatures, pose a risk to public health.”
The contaminant in question is N-Nitrosodimethylamine (NDMA), a probable human carcinogen or substance that could cause cancer. NDMA was first detected in Zantac and its generic versions in September of 2019.
How Did This All Start?
An online pharmacy called Valisure submitted a citizen’s petition to the FDA on September 9, 2019. The petition cited testing that found “extremely high levels” of NDMA in Zantac and other ranitidine medications.
Soon after, the FDA released a statement about Zantac and began investigating the complaint. Many manufacturers issued voluntary recalls as a response, and stores like Walgreens, Walmart, and Rite-Aid removed Zantac from their shelves.
In the course of its investigation, the FDA also conducted testing and found that levels of NDMA in ranitidine samples exceeded the daily limit of 0.096 micrograms or 0.32 parts per million (ppm). By October, Sanofi, the manufacturer of Zantac, had issued a voluntary recall, as well, citing:
“inconsistencies in preliminary test results.”
On November 1, 2020, the FDA released its own laboratory test results, and they were far from inconsistent. Sanofi products contained up to 0.36 micrograms NDMA and up to 2.38 ppm.
Is the Investigation Over?
The FDA’s investigation is ongoing but removing Zantac from the market is a big step. In addition to sending withdrawal letters to all ranitidine manufacturers, the FDA is encouraging consumers to stop taking Zantac and generic ranitidine medications.
Per FDA recommendations, you should safely dispose of any Zantac you still have and refrain from buying more. If you still need heartburn relief, alternatives like Pepcid, Tagamet, Nexium, Prevacid, and Prilosec are effective and have not tested positive for NDMA.
If you’ve been prescribed Zantac, talk to your doctor before switching medications.
You should also know that Zantac has been tied to cancer in several lawsuits. A New Jersey woman is suing Sanofi and other drugmakers for allegedly causing her esophageal cancer and a Florida woman alleges Zantac led to her colon cancer.
What If I Am Diagnosed With Cancer?
In order to prove Zantac is responsible for your diagnosis, you must have taken the drug for at least 1 year, be free of pre-existing cancer conditions, and sustained a qualifying injury.
Zantac has been associated with the following cancers, all of which are qualifying injuries:
- Stomach cancer
- Liver cancer
- Bladder cancer
- Cancer of the small intestine
- Colorectal cancer
- Esophageal cancer
- Prostate cancer (in those under 65)
- Pancreatic cancer
- Kidney Cancer
- Brain Cancer
- Lung cancer (in nonsmokers)
- Testicular cancer
- Ovarian cancer
- Breast cancer
- Non-Hodgkin's lymphoma
If you are battling one of these diseases and do not yet have legal counsel, we encourage you to contact ‘Maggio | Thompson, LLP immediately.
To explore your legal options during a free consultation, contact us today at (601) 265-6869 or by completing an online form.