What is Zantac?
What is Zantac (Ranitidine) Used For?
Zantac is a popular heartburn medication and blood pressure medication that has been commonly used to treat a variety of indigestion issues for the last several decades. First released in 1981, Zantac, also known by its generic name ranitidine, is an H2 (histamine-2) receptor blocker. Zantac treats conditions that cause excess stomach acid. By helping lower the amount of acid in one’s stomach, the drug relieves symptoms such as heartburn, stomach pain, and coughs caused by such conditions. Other Zantac uses are alleviating symptoms of gastroesophageal reflux disease (GERD) and esophagitis. The medication is also used to prevent stomach and intestinal ulcers from reappearing after they have healed.
Medications and drugs, by nature, contain active ingredients. This is the ingredient of the drug that reacts when it enters our bodies and is often the part of the medication that creates the desired effect (and the sometimes not so desired side effects). Zantac’s active ingredient is ranitidine (the same as the Zantac generic name). For many years, Zantac ingredients were largely considered safe for consumption (with the exception of certain possible side effects).
Side effects of Zantac
Is Zantac safe to consume? Prior to recent Zantac recalls, serious side effects to the medication were thought to be rare. Some of the most common side effects in Zantac are headache, constipation, and diarrhea. Rarer side effects include blurred vision, changes in mood, easy bleeding, enlarged breasts, severe tiredness, changes in heartbeat, infections, abdominal pain, dark urine, and yellowing of the skin or eyes. A consumer of Zantac could also have a serious allergic reaction necessitating immediate medical care.
In September 2019, new information was released after testing revealed that NDMA (N-nitrosodimethylamine) may be present in Zantac. This news alerted the FDA that there could be new and possibly dangerous side effects from Zantac. These discoveries have led to a slew of Zantac lawsuits and mass recalls.
NDMA in Zantac
NDMA is a toxic environmental contaminant and impurity that is found in some liquids and foods. The FDA has classified NDMA as a probable human carcinogen, or a substance that could cause cancer. The FDA has issued a Zantac recall because they have found that there are high levels of NDMA in Zantac ingredients. Though low levels of NDMA might not create a significant increased risk of cancer, intake of NDMA above the daily limit can be dangerous, thus the need to file a Zantac lawsuit.
NDMA is classified as a B2 carcinogen making it a probable human carcinogen according to the World Health Organization (WHO). The chemical is an unfortunate byproduct of several manufacturing processes and can often be found at industrial sites. Finding NDMA in Zantac at any higher than normal level has forced the FDA and pharmaceutical industry to wonder whether Zantac causes cancer.
There has not been a conclusive theory on how NDMA has contaminated Zantac. Carcinogen contaminants like NDMA can possibly begin to form after ranitidine becomes unstable and begins to break down. It is possible that when Zantac interacts with gastric fluids, high amounts of NDMA are created, creating a strong danger to anyone ingesting the medication.
Zantac and Cancer: Does Zantac cause cancer?
The FDA found that NDMA in combination with the Zantac active ingredient ranitidine increases even under normal storage conditions and even more so when stored in hot temperatures. The possibility that NDMA increases over time in Zantac has caused the FDA enough concern to recall the medication. Because of these new laboratory findings, there is a real question if Zantac is safe for use anymore. Doctor David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City, said of the revelation, “Drug impurities remain a major national concern…my interim advice to patients is simple: switch to another drug.” The older the medication is and the longer it has stayed on the shelf can raise the level of NDMA beyond the acceptable daily intake limit.
Toxic NDMA can cause significant damage to the human body leaving consumers to wonder if and what kind of cancer does Zantac cause. WHO has connected high exposure to NDMA with gastric and colorectal cancer. The contaminant also causes significant damage to the liver even if it does not develop cancer. However, long term use of Zantac contaminated with NDMA could be connected with lung and liver cancer. The carcinogen has also been connected with other forms of cancer such as stomach cancer, breast cancer, esophageal cancer, kidney cancer, bladder cancer, prostate cancer, and pancreatic cancer. Using Zantac long term has shown enough of a connection to these cancers that the FDA has recalled the medication, making way for Zantac lawsuits.
Zantac recall by FDA
The FDA became aware of the connection between Zantac in the summer of 2019. On September 13, 2019, the agency made an announcement explaining their concerns, warning users and manufacturers of the worrying lab results. After this announcement, manufacturers began to voluntarily recall their product. Sandoz Inc., the main manufacturer of the medicine began recalling Zantac and Zantac generic ranitidine capsule products within weeks. Following this, Apotex Corp., and several other generic manufacturers of the medication also voluntarily recalled their ranitidine products. The FDA warning announcement was the initial cause for concern for consumers.
The manufacturers of the medication reacted to the FDA’s announcement in a precautionary manner as attempts were continued to understand exactly how the NDMA is formed in their medication. The FDA in their announcement had asked manufacturers to conduct testing regarding the Zantac active ingredients and their relationship to NDMA. Questions over the “inherent instability” of the ranitidine molecule causing it to break down seem to have caused significant concern to Zantac and ranitidine manufacturers.
After significant testing was done, the FDA announced on April 1st, 2020, that it was requesting all manufacturers to withdraw all prescription and over the counter ranitidine drugs from the market immediately. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research cited concerns over uncertainty of the creation of NDMA throughout the storage of the product as the main concern for the FDA’s Zantac recall. Though the initial levels of NDMA in the medication might be low, there were questions of how much can be produced over time as the Zantac ingredients begin to break down.
Because of this announced recall, the manufacturers of Zantac could possibly be liable for any injuries derived from the NDMA in their medication and face paying settlements in Zantac lawsuits.
Joining a Class Action Zantac Lawsuit
Consumers Claim that manufacturers failed to warn of dangers between Zantac and cancer on their label
The discovery of NDMA in Zantac has given victims of various forms of cancer a possible reason behind their medical conditions. After the FDA announcements and the product recalls of the medication, consumers argue that the manufacturers of Zantac either knew or should have known about the possible NDMA risks associated with the medication. With this knowledge, the manufacturers should have warned the general public about the potential side effects before they consumed the medication to give them a better idea of the risks they may be taking.
Labels on medication are supposed to convey all possible side effects of the medication, even if the risk is low, to better inform potential consumers. Consumers have the right to know the dangers they can possibly be facing when taking certain medications. Instead of being able to balance the Zantac uses and potential risks, consumers had their choice made for them by the manufacturer, potentially violating their rights. The manufacturers of Zantac have a responsibility to manufacture safe drugs. Failing to warn of the dangers of the medication could have potentially harmed many lives.
Who is eligible to join the class action Zantac lawsuit?
There is still uncertainty over the exact dosage of NDMA in Zantac, but there is strong evidence that significant exposure to the medication leaves many vulnerable to the carcinogen. As more information on the medication is released there could be a stronger understanding of the cause and effects in the chemical reaction. That being said, long term users of the medication could have been susceptible to certain cancer developments because of the medication.
Users of Zantac for three or more months before their cancer diagnoses would likely be eligible to participate in this class action Zantac lawsuit against the manufacturers of Zantac. The FDA seems to be especially concerned in these situations, because of the growth of NDMA when Zantac is stored long term. If a user has been diagnosed with stomach cancer, liver cancer, colon cancer, intestinal cancer, prostate cancer, kidney cancer, or breast cancer after using Zantac for three or more months they may be eligible to participate in this class action lawsuit, and should contact The Law Center to assess their potential claim.
Did you take Zantac and have you been diagnosed with Cancer?
The Law Center can help
The Law Center was created for cancer patients with the mission of making positive impacts on their lives as they struggle with disease. It is imperative that people are connected to resources, support and guidance to help battle against any potential carcinogenic product or medication. The Law Center helps provide this assistance by connecting people with attorneys that could help them receive legal compensation for the pain that they have and continue to endure.
It is wholly unfair and a violation of consumers’ rights for corporations and manufacturers to misguide the public about the danger of their products. This is especially true for side effects that can have disastrous and debilitating effects on a medication user’s life. The Law Center believes in providing a legal voice for those consumers harmed by such products to ensure that such companies face the consequences for their actions. Ensuring that there is a strong legal backbone behind consumers’ rights is necessary to make sure that dishonest corporate strategies are curtailed and ended.
If you or a loved one has been affected by Zantac after using the medication for three or more months and developed a form of cancer, please contact The Law Center. Together, with the other consumers of the medication, we can show drug manufacturers that their dangerous actions will not be tolerated. Though individually it might be hard for one’s voice to be heard, together we can ensure that our collective voice is loud enough to reach these manufacturers.
The team at the Law center was especially made to help cancer patients in such situations. If you or a loved one have been affected by Zantac and are seeking relief for yourself or your family to help ease the financial burden of the disease, reach out to The Law Center for further guidance and a free case evaluation.
Sources
- https://www.nytimes.com/2020/04/01/health/zantac-cancer-fda.html
- https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
- https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
- https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and
- https://www.healthline.com/health-news/fda-warns-zantac-may-have-carcinogen#What-is-NDMA?
- https://www.webmd.com/drugs/2/drug-4090-7033/zantac-oral/ranitidine-tablet-oral/details
- https://www.webmd.com/heartburn-gerd/news/20190913/zantac-heartburn-drug-may-contain-carcinogen#1
- https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911