Ranitidine, the drug more commonly referred to by its brand name Zantac, has been a widely-used prescription heartburn medication since it first debuted in the early 1980s. In fact, the World Health Organization (WHO) included ranitidine on its List of Essential Medicines as recently as 2017.
But in the past year, Zantac has been making headlines for more troubling reasons. Patterson Legal Group presents these five facts consumers should know about ranitidine, cancer, and whether filing a lawsuit against Zantac is right for you.
#1: Zantac Contains N-Nitrosodimethylamine (NDMA)
In September 2019, the Food and Drug Administration (FDA) released a statement identifying certain ranitidine medications including Zantac as containing a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
NDMA occurs naturally in water and foods such as dairy, meat, and vegetables. In small doses, it poses little threat to human health. Laboratory analysis by the FDA concluded that consumers could safely ingest up to 0.096 micrograms or 0.32 parts per million (ppm) of NDMA per day. In a November 2019 statement regarding the lab’s findings, the agency cautioned that too much consumption of NDMA could lead to adverse health consequences.
#2: NDMA Is a Probable Human Carcinogen
Although NDMA occurs naturally, ingesting too much of the contaminant over time can be dangerous. Through its investigation into the effects of NDMA and ranitidine, the FDA concluded that NDMA is a probable human carcinogen, meaning that it is a substance that could possibly cause cancer.
Although early FDA laboratory research seemed to indicate low levels of NDMA occuring in ranitidine products like Zantac, additional research by third-party laboratories including Valisure Pharmacy has since proven that the amount of NDMA in ranitidine increases significantly when stored above room temperature.
The research, evaluated by the FDA, also suggested that NDMA levels are likely to increase over time, even under ideal storage conditions at room temperature. Furthermore, Zantac products may have been subjected to higher temperatures during the distribution and handling process, leading to increased risk of NDMA exposure.
#3: The FDA Has Requested the Removal of All Ranitidine Drugs from the Market
On April 1, 2020, the FDA formally requested all drug manufacturers to withdraw all prescription and over-the-counter (OTC) medications containing ranitidine. Because NDMA levels are prone to increasing over time and when stored above room temperature, the FDA has determined that medications like Zantac may result in consumer exposure to an unacceptable amount of this probable carcinogen.
As such, Zantac and other ranitidine-containing medications are no longer available for new or existing prescriptions or over-the-counter usage and consumers have been advised to properly dispose of medications containing ranitidine and consult their medical providers for alternative treatment of conditions such as heartburn, GERD, or peptic ulcer disease.
#4: Zantac May Be Linked to Cancers of the Bladder, Stomach, and Liver
Multiple parties have now filed a lawsuit against Zantac and the pharmaceutical companies that manufacture it or its generic form, including Sanofi and Pfizer. Plaintiffs allege that ranitidine is an inherently unstable chemical, one that can easily break down into NDMA in the human digestive system. Their claims are based upon a 2016 Stanford study that found levels of NDMA in human urine samples increased dramatically after ingesting a standard 150 milligram dose of ranitidine.
Longtime users of products like Zantac who have been diagnosed with cancer argue that long-term use of medication containing ranitidine is directly responsible for increased rates of gastric cancer, liver cancer, and bladder cancer. They also allege that the makers of Zantac failed to adequately warn consumers of the risks associated with ranitidine consumption.
#5: Zantac Consumers May Be Eligible for Compensation
If you or a loved one took Zantac or another medication containing ranitidine for a prolonged period (at least 60 days) and later developed stomach, liver, or bladder cancer, you could be entitled to compensation for your medical bills, lost wages, pain and suffering, and in cases of wrongful death, funeral costs.
Filing a lawsuit against Zantac may take time as evidence continues to emerge, but having an experienced personal injury lawyer on your side can help you bring your case to a fair resolution as quickly as possible.
Contact Patterson Legal Group today by calling 888-687-2400 to schedule your free consultation and case review. Representatives are standing by to answer your questions online, or you can send us a message using our secure contact form.