Zantac has been a well-known and supposedly reputable medication for years, and it has long been available both over-the-counter and by prescription in both brand name and generic forms. Millions of Americans have turned to the drug for help with heartburn, but some have alleged that there is a dangerous link between Zantac and cancer.
Now, lawsuits, recalls, and shocking revelations of carcinogens in patients have drawn Zantac and its generic form into the legal spotlight.
Zantac, known generically as ranitidine, is a medication intended to prevent and relieve acid reflux problems. Higher strengths are available by prescription only for especially severe conditions (like those that cause ulcers), while over-the-counter preparations are available to the average consumer to treat mild symptoms.
The brand name product Zantac is produced and sold by pharmaceuticals manufacturer Sanofi, while generic ranitidine is available from a variety of manufacturers.
Zantac is a member of the H2 (histamine-2) blocker class of drugs, which are used to reduce stomach acid in patients with chronic heartburn and/or gastroesophageal reflux disease (GERD). The drug effectively blocks the body’s histamine from activating stomach cells’ H2 receptors, preventing the production of acid. The effects eventually wear off and the stomach returns to making acid normally, but the temporary break reduces the overall acid volume and gives time for ulcers and other damage to heal.
In September of 2019, an online pharmacy company called Valisure informed the FDA that they had found a serious risk for the development of dangerous amounts of n-nitrosodimethylamine (NDMA) across all ranitidine products tested (brand name Zantac included), regardless of manufacturer. Startled by their findings, the company immediately notified the FDA, setting off a wave of recalls.
NDMA is a common environmental contaminant introduced by things like industrial waste, pesticides, and even rocket fuel. It also can be introduced during certain water treatment processes. It shows up in a variety of places—including drinking water—but not usually in great amounts.
In the case of Ranitidine, however, the greatest risk lies in the fact that the drug appears to be chemically unstable, making it possible for the molecules to produce NDMA in the body after it is ingested. This is a serious concern, as research has suggested quite strongly that ingesting high doses of NDMA can increase the risk of stomach or colorectal cancer.
Many have questioned the FDA’s response to the information they received from Valisure. The online pharmacy’s test results found approximately 2.5 nanograms of NDMA potential per 150 milligrams of Zantac—over 26,000 times the FDA limit. However, when the FDA announced its own investigation of the claims, they used the words “trace amounts” to describe the possible levels of NDMA exposure to patients.
Victims and their legal teams argue that not only have the manufacturers failed to prevent the introduction of NDMA to patients, but the FDA has also failed to protect the public by intentionally minimizing the situation in their response. The fact that the FDA did not recommend that patients stop taking ranitidine during their investigation of the issue raises serious concerns, as well.
In response to the discovery of NDMA production potential across ranitidine products, a number of manufacturers have chosen to recall any lots where testing shows results suggesting possible NDMA levels above the FDA’s daily permissible intake.
Companies that have voluntarily recalled their ranitidine products include (but are not limited to):
As the situation continues to unfold, it is likely that other companies and manufacturers will continue to issue recalls and warnings. Hopefully, the FDA’s investigation of this widespread problem will bring the root cause of the issue into clearer focus. Until then, many who have been using ranitidine regularly have stopped taking it.
After the news that Zantac had been linked to a probable human carcinogen, many patients who had been taking the drug began to recognize a potential link between their use of ranitidine and their cancer. Now, victims like these are filing lawsuits alleging that the drug is clearly the cause of their disease.
As of late 2019, California’s Northern District is considering a proposed class-action lawsuit against ranitidine in which four victims take Sanofi-Aventis U.S. and Boehringer Ingelheim to task. They allege that not only was there clear deception and failure to protect consumers from dangerously high levels of NDMA but also that the degree to which brand name Zantac is capable of producing NDMA in the body is especially egregious.
While manufacturers and the FDA have acknowledged the evidence of Ranitidine’s ability to be converted into a probable human carcinogen, they don’t seem to be acknowledging the true degree to which they failed to protect and warn the public. For those who say that Zantac caused their cancer, the idea that such widespread failure to protect patients across multiple manufacturers was missed for so long is suspicious at best.
This is a complicated question. The evidence regarding the presence of large amounts of NDMA in patients’ bodies suggests a strong likelihood that the unstable drugs played a role in increasing cancer risk. Hypothetically, however, Zantac from a lot that does not show the same risk of producing NDMA should not pose a risk of cancer.
Because the discovery of this NDMA issue is so recent, it remains to be seen whether or not manufacturers will truly keep their products safe from such issues in the future. If they can’t keep their products clean and safe, Ranitidine may still pose a cancer risk.
If you believe that you or a loved one have developed cancer as a result of taking unstable Zantac/Ranitidine that produced carcinogens in your body, you may be entitled to compensation for the harm that was done. Whether or not you truly have a good case for court depends on a variety of factors, of course, including the amount and quality of available evidence. If your case is suited for it, your lawyer may recommend that it be filed with others under a ranitidine class-action lawsuit.
The best way to find out for sure whether you have a good case is to speak with an attorney like those at Saunders & Walker, P.A. who are experienced in harmful drug cases. In a consultation, your lawyer will be able to examine your situation, determine if it’s appropriate for a lawsuit, and help you begin collecting the evidence you need to strengthen your case for trial.
At Saunders & Walker, P.A., we are experts in personal injury and harmful drug lawsuits. Our entire team is dedicated to holding those at fault accountable for their negligence, as well as helping victims of unsafe products get the help they need and deserve. We know pharmaceutical companies’ legal tactics inside and out, which means we know how to combat them at every turn.
With numerous certifications and the highest possible peer review rating from LexisNexis Martindale-Hubbell, we’re proud to say that Saunders & Walker, P.A. is a trusted and respected law firm. We have decades of experience in the area of product liability, which is why clients ask us to represent them again and again.
You trusted Zantac manufacturers to help you prevent and treat acid-related stomach problems. If you believe you’ve developed cancer as a result of taking unstable ranitidine, it’s time to call them out for breaking that trust. To find out whether you have a case for a ranitidine lawsuit, call us today at (727) 579-4500 to schedule a free initial consultation.