Valisure pharmacy (New Haven, CT) tests medications before shipping them to patients. The panels they run on the drugs range from dosage levels and chemical makeup to unacceptable levels of contaminants and human carcinogens. Approximately 10 percent of the batches that the pharmacy tests are identified as failing to meet standards. Valisure reports their findings to the drug manufacturers.
In early 2019, Valisure ran a carcinogen test on antacid drugs and ranitidine, which is the active ingredient in the brand name Zantac. Ranitidine products are h2 blockers that reduce the amount of stomach acid. Zantac and generic Zantac is sold as a popular heartburn medication both over-the-counter and prescription, for acid reflux and gastroesophageal reflux disease (GERD). Sanofi is the drug manufacturer of the brand name Zantac.
The initial numbers for contamination rose sharply showing alarmingly high levels of NDMA (the chemical n-nitrosodimethylamine), a probable human carcinogen. The acceptable level of NDMA is 96 nanograms (per day.) In their testing, Valisure found 2,511,469 ng of NDMA in one OTC Zantac tablet.
NDMA was used at one time to make rocket fuel. It is now used on laboratory animals to induce tumors in them. NDMA is a well-documented cancer-causing chemical in animals. Both the U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) classify NDMA as a probable human carcinogen because of what it does in animals. Even the CDC calls attention to its risks. The World Health Organization (WHO) links NDMA to colorectal and gastric cancer.
Valisure ran more tests on the ranitidine, including sending samples to an independent lab. Ranitidine the active ingredient in Zantac, also converts into NDMA (n-nitrosodimethylamine) once it is in the stomach.
Valisure reported their findings to the U.S. Food and Drug Administration (FDA) in June 2019. By July, they filed a Citizen’s Petition with the FDA stating that the NDMA in ranitidine medications made for heartburn is likely caused by the instability of the ranitidine molecule.
FDA advises ranitidine products recall including Zantac recall
The FDA issued a safety warning in September of 2019. The FDA statement advised that some ranitidine products contained low levels of NDMA. Major retailers like CVS, Rite Aid, Walgreens, and Walmart stopped selling over-the-counter Zantac (OTC) and generic ranitidine. Generic drugmakers did a voluntary recall of generic ranitidine in response to the FDA statement.
Drug manufacturer Sanofi issued a voluntary recall of the over-the-counter (OTC) heartburn drug Zantac in the United States. Zantac 150, Zantac 150 Cool Mint, and Zantac 75.
In April 2020, the U.S. Food and Drug Administration (FDA) requested all ranitidine products in the United States be recalled, including a Zantac recall. They named the presence of NDMA (n-nitrosodimethylamine), a probable human carcinogen, was found in the ranitidine drugs.
As of July 2020, NDMA was found in heartburn, diabetes, and blood pressure medications. Blood pressure and congestive heart failure medications using the drug valsartan have been recalled. Valsartan is an angiotensin receptor blocker (ARB). In the case of valsartan, the presence of NDMA was by accidental cross-contamination. Unlike the drug valsartan, Zantac poses an additional source of n-nitrosodimethylamine contamination which is the ranitidine drug itself.
Joseph Galimidi filed a lawsuit against the drug manufacturer Sanofi. He used Zantac to treat acid reflux and heartburn in 2009. In 2013, Galimidi was diagnosed with breast cancer. His lawsuit seeks damages related to his cancer diagnosis. He claims the drug manufacturers had knowledge about the risks of NDMA in Zantac, but did not disclose the risks to the public.
In October 2019, Mark Allen Blake sued several Zantac and ranitidine drug makers. He used the drug four times per week over 23 years. He was diagnosed with bladder cancer in 2018. The following year, he learned about NDMA in Zantac in an article online. Had he been advised of its risk, he says he would not have taken it.
Zantac (Ranitidine) class-action lawsuit
On September 13, 2019, four plaintiffs filed the first Zantac class-action lawsuit in the Northern District of California of federal court. It is against drug manufacturers Sanofi and Boehringer Ingelheim. A week later, the second class-action lawsuit was filed in the District of New Jersey. Following this, were class-action lawsuits filed in New York and Connecticut.
In February 2020, the United States Judicial Panel on Multidistrict Litigation (JPML) consolidated over 120 cases under Judge Rosenberg in Florida, into a single multidistrict litigation (MDL), MDL No. 2924. As of September 2020, this mass tort action against big pharma drug companies GlaxoSmithKline Sanofi, and Boehringer Ingelheim, now represents over five hundred plaintiffs.
The Zantac (ranitidine) MDL No. 2924 March court date was postponed by Judge Rosenberg due to COVID-19. Since then, fact discovery is set to be completed by December 21, 2021.
Side effects that Zantac Causes
Common side effects that have been reported by users of Zantac (ranitidine) can include:
- Skin Rash
- Stomach Cramps
Cancer risks that Zantac Cause
There are several cancer risks that are associated with NDMA exposure by taking Zantac. They are as follows:
- Bladder Cancer
- Breast Cancer
- Colorectal Cancer
- Esophageal Cancer
- Kidney Cancer
- Liver Cancer
- Pancreatic Cancer
- Prostate Cancer
- Stomach Cancer
- Testicular Cancer
- Uterine Cancer
What does this mean for you if you, a loved one, or family member have taken prescription or OTC Zantac (Ranitidine)?
If you, a loved one, or a family member have taken Zantac 150, Zantac 150 Cool Mint, Zantac 75, generic Zantac (ranitidine), and have experienced the any of these side effects or cancer risks associated with this drug, please call us.
If you are not sure NDMA exposure caused your medical condition, an expert at our law firm can evaluate your case with you. We will review any medical bills, personal injury claims, and any health care conditions that may be related.
Please call us now for your free consultation and case evaluation.