Published on January 23, 2020
If you have taken the popular acid-reducing medication Zantac to help with a variety of issues, including things like peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome, then you may have been aware of an ongoing voluntary recall for the product. As of April 1, 2020, however, the FDA has formalized the Zantac recall and mandated that all ranitidine products be removed from U.S. markets. Zantac and other generic medications of the same compound, ranitidine, are being recalled by distributors such as Walmart, CVS, Rite Aid, and Walgreens, who are offering customers a refund for the product. In addition, a variety of pharmaceutical companies have discontinued the production of the medication until further notice.
If you have taken Zantac and are concerned about the possible cancer-causing issues associated with it, take a look below to learn more now. If you believe that you are in need of legal assistance in order to help you navigate this process, join a class-action lawsuit, or seek your own legal action against any number of producers, distributors, or prescribers, then contact the team at Balkin & Mausner as soon as possible. Our personal injury lawyers are trustworthy and aggressive.
Read more below to learn about the ingredients in Zantac that cause cancer.
What is Zantac?
Zantac (ranitidine) was a popular acid-reducing medication that belongs to a family of drugs known as histamine-2 blockers and has been used to treat and to prevent ulcers in the stomach due to high levels of acid. The medication was used to treat symptoms relating to Zollinger-Ellison syndrome, and to treat gastroesophageal reflux disease (GERD) as well as a range of other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.
However, Zantac was found to contain an impurity known to cause cancer called NDMA, or N-nitrosodimethylamine, and was removed from shelves as a result.
Are Generic Versions of Zantac (Ranitidine) Equally Risky?
If you have any version of ranitidine that you take for heartburn or other stomach acid-related issues, speak with your doctor immediately to create a plan to discontinue use and move to a safe medication to continue treating your stomach issues.
Fortunately, there are a number of safe alternatives such as Esomeprazole (brand name Nexium), Lansoprazole (brand name Prevacid), or Omeprazole (brand name Prilosec). Do not discontinue use on your own, as this can cause harmful side effects that may result in serious damage to your stomach.
Why Was Zantac Recalled?
The recalls were in response to an FDA notice (and series of ongoing updates) that Connecticut-based online pharmacy Valisor had identified the presence of a contaminant known as NDMA, or N-nitrosodimethylamine. This contaminant is listed as a probable human carcinogen because it likely can cause cancer after long-term, high-dose exposure in humans. The dosages found in any testing of Zantac or the generic versions of the drug had been found to produce low levels of NDMA, but the FDA still instituted a mandatory recall of the drug.
When Zantac and ranitidine are being processed by the body, the compound has been shown to produce NDMA in low levels. The FDA suggests that any exposure to NDMA in excess of 96 nanograms per day or 0.32 parts per million for ranitidine is an unacceptable level, and could be potentially dangerous. They have additionally released a series of their own lab test results for a variety of pharmaceutical producers, and have encouraged producers to perform and submit their own lab results as well in order to provide a more comprehensive picture of the risks inherent with each product.
It is important to note here that neither Zantac nor ranitidine is carcinogenic in nature. When heat is applied to the medication, it generates a byproduct of the impurity NDMA, or N-nitrosodimethylamine. It is this compound that is the cause for concern, but this is still an ongoing debate about whether or not the testing methods used in order to identify this concern were appropriate or not.
The essential issue around testing methods is that Valisor had heated the medication to a high temperature in order to produce dangerous levels of NDMA, temperatures that do not reflect the conditions present in the body as the medicine is being digested and metabolized. In fact, the FDA has stated that the levels of NDMA present in Zantac and ranitidine are “similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
What Kind of Cancer Does Zantac and Ranitidine Cause?
Regardless of the debate around safe levels of exposure, NDMA is listed as a probable carcinogen, meaning that it is shown to increase the risk of certain cancers in humans. In this particular instance, the risks of cancer associated with Zantac, ranitidine, and NDMA are gastric, or stomach, cancers such as gastric adenocarcinoma or Gastrointestinal Stromal Tumors. Again, the risk of these cancers is rare and is still up for debate in terms of exposure to levels of NDMA present in these medications.
In addition to stomach cancers, there are concerns that Zantac, ranitidine, and the associated presence of NDMA may also cause colorectal cancers or possible bladder cancers. If you had been taking Zantac and were diagnosed with any of the following conditions, you should speak with an attorney:
- Stomach Cancer
- Liver Cancer
- Bladder Cancer
- Small Intestine Cancer
- Colorectal Cancer
- Esophageal Cancer
- Prostate Cancer
- Pancreatic Cancer
- Kidney Cancer
- Brain Cancer
- Lung Cancer
- Testicular Cancer
- Ovarian Cancer
- Uterine Cancer
- Nasal/Throat Cancer
- Thyroid Cancer
The levels found in testing results are similar to levels found in a variety of foods that humans eat on a daily basis with little known increase of cancer. However, Zantac has been recalled in the United States and is no longer available.
Symptoms of Cancer Caused by Zantac
If you or a loved one has a history of taking Zantac or other over the counter ranitidine drugs, it is important to stay alert for the following symptoms, which may be symptoms of cancer caused by NDMA in the medication:
- Uncontrolled weight loss
- Black, greasy, or tarry stool
- Decreased appetite
- Nausea and vomiting
- Fatigue, weakness, or dizziness (signs of anemia)
- Dark or bloody urine
- Yellowing skin
- Painful and burning urination
- Itchy skin
- Increasingly irregular bowel movements
- Back pain
- Abdominal pain that is not related to heartburn
These symptoms and more may be an indication of something more serious, such as cancer caused by harmful exposure to NDMA in Zantac or ranitidine medications. If you are experiencing any of these symptoms, contact your attorney as soon as possible to get medical attention and determine how to move forward with this situation.
What is Ndma?
NDMA, or N-nitrosodimethylamine, is a known carcinogen that has been found to occur in Zantac or ranitidine when exposed to high temperatures. According to the news outlet Chemical and Engineering News “NDMA is an N-nitrosamine, a type of compound that has the generic chemical structure R2N–N=O, a deprotonated amine bonded to a nitroso group. N-nitrosamines are generally formed when a secondary or tertiary amine reacts with a nitrosating agent. The compounds are found at low levels in many foods, such as roasted meats, cheese, and beer, because of cooking and fermentation processes.”
Is Zantac Still Being Sold?
On April 1, 2020, the FDA requested that all drug manufacturers producing Zantac or its generic medication ranitidine remove the products from shelves and discontinue production. According to the FDA press release: “The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.”
Contact Us Today
If you would like to understand more about your options if you are concerned about your exposure to NDMA due to the use of any of these popular acid-reducing medications, contact Balkin & Mausner as soon as possible for a free initial consultation. We will be able to connect you with an attorney who can help you understand your rights and options as a consumer, and what the most appropriate steps forward are to ensure that you get the legal help you deserve.