Legal action is underway regarding the potential link between Zantac heartburn medication and cancer. The US Food and Drug Administration (FDA) is investigating Zantac (ranitidine) after it was determined that the popular heartburn and acid reflux medication contains potentially high levels of N-nitrosodimethylamine (NDMA). NDMA is a known carcinogen.
As a result of the finding, sales of the drug have been suspended in US stores. Three pharmaceutical companies have issued recalls for their versions of ranitidine.
People are exposed to naturally NDMA in foods, drinks, and the environment, but the dosage is small enough that is not believed to be dangerous. But the amount contained in Zantac is dangerous – anywhere from 3,000 to 26,000 times higher than what the FDA considers safe.
There is also concern about the risk increasing over time based on how the medication is stored.
According to the FDA, “… 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.”
The FDA is still trying to determine how NDMA was introduced into Zantac and other medications like it. It is known to be unintentionally produced in and released from industrial sources via chemical reactions, including those that involve alkylamines. NDMA is also known to contaminate air, soil, and water.
Why is NDMA Dangerous?
The Environmental Protection Agency (EPA) describes NDMA as a “semi-volatile organic chemical.” It is formed through industrial and natural processes but is only produced commercially and in its pure form for research purposes in the United States. It was previously used in the production of antioxidants, additives for lubricants, rocket fuel, and softeners for copolymers. It is also an unintended byproduct of the chlorination of wastewater and drinking water at treatment plants that disinfect with chloramines.
The primary reason exposure to high levels of NDMA is dangerous is because it’s a known carcinogen.
It has been linked to several different types of cancer, including:
- Small intestine
- Non-Hodgkin’s Lymphoma
The degree of risk varies among the types of cancer and from person-to-person.
In addition to cancer, overexposure to NDMA carries a variety of other risks and triggers several side effects, including:
- Abdominal cramps
- Reduced liver, kidney, and lung function
Makers of Zantac Might Have Been Aware of the Risks
Many of those affected after using Zantac and other versions ranitidine have filed claims against the manufacturers of the drugs. According to the claims, manufacturers knew of the high levels of NDMA in their products and hid the danger from consumers.
Lawsuits claim manufacturers of Zantac were negligent and guilty of wrongdoing concerning the design, development, manufacture, testing, packaging, promoting, marketing, advertising, distribution, labeling, and/or sale of the drug Zantac.
Additionally, claims allege negligence, several breaches of contract and warranty, negligent misrepresentation, fraud, and deceit, as well as a violation of the New York Consumer Protection Act. One lawsuit also alleges loss of consortium.
Claims call the product “defective, dangerous to human health, unfit, and unsuitable to be marketed and sold in commerce…” Lawyers for plaintiffs believe that research will show that this will be “… one of the gravest public health frauds in modern times.” Plaintiffs have also called Zantac a “cancerous poison.”
Those who used the medication and can prove they did so and were later diagnosed with any of the types of cancer linked to NDMA exposure, and can prove that to be the case through medical records could potentially pursue legal action. Proving a link between the use of a product and the development of a serious side effect such as cancer can be complex. Anyone who believes they have been affected should speak to an attorney familiar with the situation.