Friday, August 12, 2022

Reasons for the Zantac Recall

Written by Malman Law, reviewed by Steve J. Malman.

Zantac, also known as ranitidine, has been available to heartburn sufferers in America since the early 1980s. Since then, millions of patients have used it to provide relief from this uncomfortable condition. Zantac was the first pharmaceutical drug to receive $1 billion in sales. However, these sales came at the cost of human life and dignity for some patients who took the drug. Until recently, there were no significant problems with this medication or recalls. However, that changed in the fall of 2019. Upon learning of this recall and considering their health issues, many patients have reached out to Zantac lawyers to find out what legal recourse they potentially have.

Why was Zantac Recalled?

The United States Food and Drug Administration (FDA) issues recalls of drugs and other products when there are health and safety concerns. The recall of Zantac began in the fall of 2019 and continues far into 2020. Shortly before the Zantac recall, it was discovered that some ranitidine samples contained a chemical known as N-Nitrosodimethylamine or NDMA. This chemical has been found to cause cancer in animals and is a suspected human carcinogen. 

The FDA advises that humans should have no more than 96 nanograms of NDMA each day. However, some Zantac preparations have been found to contain over 3,000,000 nanograms per tablet. Considering that patients on Zantac take at least one tablet per day, sometimes as many as three or four, this number is quite alarming. Additionally, some studies revealed that the levels of NDMA in each tablet could grow over time, with heat, and when swallowed and mixed with the body’s natural chemistry in the stomach. All of this evidence was too much to be ignored by the FDA. To help protect Zantac users from the potential cancer risk, this drug was recalled. This prompted many patients to consult with knowledgeable Zantac attorneys.

According to an FDA press release issued on April 1, 2020, the agency requested drug manufacturers of ranitidine to remove their prescription and over-the-counter (OTC) drugs containing the substance. This action permitted the FDA to continue to investigate the substance (NDMA), known medically as N-Nitrosodimethylamine.

The press release added that the impurity of some of the ranitidine-based drugs increases over time, which affects consumer health. 

Not only is NDMA created during the manufacturing process, but it is also found in the solvents that are used during processing. In addition, a third-party lab concluded that unsafe levels of NDMA may not materialize until delivery of the drugs or after they’re stored. 

While a market withdrawal is used to address small violations of the FDA’s mandates, the FDA will not take legal action unless there is a recall. A recall involves the revision or removal of a marketed product that violates the FDA’s guidelines.

All Zantac products made with ranitidine are no longer sold. However, one company, Sanofi, did reformulate the brand drug Zantac 360 with famotidine. This drug is available over the counter. The FDA has not found NDMA contamination in this reformulated drug. Therefore, it has been sanctioned as a safe alternative.

Otherwise, if you have taken Zantac or the generic equivalent of the drug (ranitidine), you need to speak to a Zantac cancer lawsuit attorney if you were diagnosed with cancer. You may qualify for compensation.

Zantac Lawsuits

There is evidence supporting that Zantac’s manufacturers were well-aware of its potential link to cancer when it was first introduced on the market. Drug manufacturers have a legal and ethical duty to warn patients about potential risks and to remove drugs from the market/not place them on the market if they are harmful. The manufacturers of Zantac are accused of not fulfilling this duty, thereby putting them at risk legally. Patients who took Zantac for any length of time and subsequently were diagnosed with cancer may have an injury claim against the manufacturer’s and should contact experienced Zantac lawyers as soon as possible.

More About NDMA

NDMA, the contaminant and probable carcinogen in Zantac, is dangerous when the user is exposed to high doses of the substance. It is closely linked to a large number of cancers. When taken in small doses, it may also damage the liver.

Zantac lawsuits have sprung up from complaints from Zantac consumers who were diagnosed with cancers involving the stomach, kidney, bladder, liver, pancreas, colon, and breast. That is just a small listing. The complete list of cancers is non-exhaustive and therefore does not show all the medical issues that may arise from taking the drug.

Meet with Zantac Lawyers to Find Out if You Have a Legal Case

Americans trust that when they take an FDA-approved medication that it will be safe. When Zantac users realize this trust was not warrantied, it can be devastating. If you or someone you love suffered or even died because of the link between Zantac use and cancer, your best course of action is to speak with an attorney. To schedule your free no-obligation consultation with the experienced Zantac attorneys at Malman Law, call (312) 629-0099 or use our online contact form.