The Food and Drug Administration (FDA) requested that manufacturers and retailers remove all products containing ranitidine in early April 2020. The sudden disappearance of these medications—including Zantac—was surprising to many people.
Why was Zantac taken off the market? Review the reasons behind the FDA’s decision right here. Find out more about possible connections between Zantac and an increased risk of cancer.
Concerns that Zantac Contains Cancer-Causing Substances
In short, Zantac was taken off the market due to concerns that it contained dangerous levels of N-Nitrosodimethylamine (NDMA). NDMA is classified as a “probable human carcinogen.” Carcinogens are substances that could increase the odds of cancer development.
Concerns regarding the presence of NDMA in Zantac—and other products containing ranitidine—first arose in September of 2019. At that point, the FDA began testing that initially found small amounts of NDMA in ranitidine products. Due to these results, the FDA urged individuals who used ranitidine products to look into alternate treatments.
However, testing continued throughout the end of 2019 and into 2020. Third-party laboratories provided additional information that showed that levels of NDMA in ranitidine products increased in normal storage conditions. These levels rose extensively at high temperatures. Levels of NDMA also increased as the product grew older.
Dangers of Exposure to N-Nitrosodimethylamine (NDMA)
As we mentioned, NDMA is a probable human carcinogen. This substance was first identified as dangerous by the World Health Organization (WHO) in 2006, so the risk is not a new discovery. However, it was not previously realized that ranitidine products could contain NDMA in dangerous amounts.
NDMA is also found in contaminated drinking water, in some cases.
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Results of Health Risks Associated With Ranitidine
All of the factors we discussed could result in ranitidine products containing levels of NDMA that exceed the daily allowable intake level. Therefore, in April 2020 the ranitidine recall expanded. The FDA made the decision to request ranitidine products be taken off of the market. Additionally, the FDA recommends that:
- Manufacturers withdraw their products from the market.
- Consumers stop taking ranitidine.
- Consumers dispose of any ranitidine they currently have.
- Doctors help patients find alternatives to ranitidine products.
The warnings related to ranitidine products apply to both liquid and tablet forms of the medication. The FDA recommends individuals cease the use of Zantac as well as other, off-brand forms of medication that contain ranitidine. Both prescription and over-the-counter forms of ranitidine mediations should be avoided, according to the FDA.
Health Risks Associated With Exposure to NDMA
As we mentioned, NDMA is a likely carcinogen. There are concerns that this substance could lead to the development of many different forms of cancer, including cancer of the:
- Esophagus, stomach, intestines, and colorectal area
- Kidneys, liver, pancreas, and bladder
Studies suggest that NDMA exposure could also lead to testicular, ovarian, or uterine cancer. This extremely hazardous substance works as a hepatotoxin. Hepatotoxins damage the liver, even if they do not cause cancer. Exposure to dangerous levels of NDMA often have immediate impacts on an individual’s health.
Individuals who are exposed to high amounts of NDMA could develop a fever or headaches as minor symptoms. More serious symptoms include dizziness, nausea, vomiting, and abdominal cramps. Some patients develop jaundice—or yellowed—skin. organ function is also impacted by hepatoxicity.
Legal Options to Handle Health Damage From Ranitidine
There are a number of legal cases currently pending due to the potential negative health effects of ranitidine usage. Individuals who developed cancer from exposure to this dangerous substance are seeking compensation for their:
- Medical expenses
- Lost wages
- Lost earning potential
- Pain, suffering, and mental anguish
Note that, as more information becomes available about ranitidine use, it is possible that we will discover that the use of Zantac led to many wrongful deaths. Individuals who lost a family member due to cancer caused by ranitidine usage could potentially be able to seek compensation for funeral and burial costs, as well as other damages suffered.
Some individuals are filing direct lawsuits against the companies responsible for producing ranitidine products. These lawsuits are focused on holding the company accountable for selling a product with potentially cancer-causing ingredients.
There are also a number of potential class action lawsuits in various stages of development. Individuals who lost a loved one to cancer caused by ranitidine or individuals dealing with a cancer diagnosis could seek compensation for their losses through legal means.
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Discuss Why Zantac Was Taken Off the Market With a Lawyer
So, why was Zantac taken off the market? The FDA requested the removal of this drug because of the potential for exposure to NDMA, a probably cancer-causing substance. If you believe that you have developed a serious medical condition as a result of the use of Zantac, reach out to a lawyer today to get help. Find out more by contacting Friedman & Simon, L.L.P. Just call (516) 932-0400 or complete our online contact form.