Beginning in September 2019, the U.S. Food and Drug Administration (FDA) had a lot to say about Zantac. When it comes to Zantac, the FDA says it actively manages concerns over the levels of N-nitrosodimethylamine ( NDMA ) in generic versions of ranitidine heartburn and reflux medications. The FDA sets the daily allowable intake limit for this medication at 96 nanograms per day. When they tested ranitidine samples, many exceeded this daily limit level.
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The FDA’s concern over NDMA is that it is a “probable human carcinogen,” meaning it can likely cause cancer in humans based on laboratory tests. It is a known carcinogen in animals, and may be used to cause tumor growth for research on mice, rats, hamsters, and other rodents.
As of March 2020, the FDA believes that Zantac and similar drugs only contain low levels of NDMA. It is important that drug manufacturers, distributors, and the general public understand the potential risk surrounding Zantac and NDMA. The FDA wants to give consumers adequate warnings about the presence of a cancer-causing chemical.
Zantac was recalled because of NDMA contamination. The FDA has also recommended similar recall actions for companies that produce certain blood pressure and heart failure drugs. Known as angiotensin II receptor blockers or ARBs, the FDA began investigating unacceptable levels of NDMA in these drugs in 2018, and there have been several voluntary recalls due to their high levels within this substance.
In September 2019, when the FDA announced NDMA contamination, the agency did not call for people who take Zantac or other ranitidine-based drugs to stop using them. They believe the contamination to be only slightly above allowable levels and not immediately dangerous.
The FDA says this about Zantac: “Those who are prescribed prescription Zantac (ranitidine) and want to change medications should discuss it with their doctor to determine another treatment option and get a new prescription. Those who take a ranitidine product sold over the counter may consider changing to a different medication to help manage heartburn or acid reflux.”
The FDA stressed that there are several heartburn medicines on the market that are effective for stopping acid reflux, preventing damage to the esophagus from acid, and other similar uses as Zantac.
While the FDA stands by its testing and findings that the levels of contamination in the affected ranitidine products are only slightly above allowable levels, those filing lawsuits against the drug manufacturers see things differently. According to legal documents filed in the ranitidine cancer and Zantac multidistrict litigation (MDL), there have been almost 200 studies and articles that connect NDMA to high risk of cancer in the human body, including tumors originating in a wide range of areas, such as:
If you’ve been harmed after taking Zantac, you should consider hiring a personal injury lawyer.
While the claimants believe possible NDMA contamination is a problem and could potentially cause cancer and other significant medical concerns, they allege that there is a bigger problem with ranitidine. The documents filed as a part of the MDL claim that Zantac, in combination with certain common foods, metabolizes into much higher levels of NMDA.
This could be as high as “tens of thousands of times” higher than the daily threshold the FDA considers an acceptable limit in medications. To make matters worse, the foods that cause this increase also might trigger heartburn, so a person is likely to use this medication in conjunction with eating high-nitrate foods.
In April 2020, the FDA requested that all Zantac and other ranitidine products be pulled from the market due to concerns over NDMA contamination. The agency advised consumers to stop taking the medication immediately and to dispose of any remaining supply. The request came after ongoing investigations found that the levels of NDMA in some ranitidine products could increase over time and when stored at higher than room temperature.
Since then, several drug manufacturers have issued voluntary recalls of their prescription ranitidine products. In February 2021, the FDA announced that it had reached a settlement with GlaxoSmithKline, the manufacturer of Zantac, to resolve claims that the company failed to disclose known cancer risks associated with the drug.
Currently, there are ongoing legal battles surrounding Zantac and other ranitidine medicines. The FDA continues to advise consumers not to use any products containing ranitidine and to consult with their healthcare providers about alternative treatment options for conditions such as heartburn and acid reflux.
If you took Zantac and believe it may have played a role in your cancer or another significant medical condition, such as liver failure, Zanes Law may be able to help you gain financial compensation. We can evaluate the merits of your case, explain your legal options, and sign you up for representation during your initial case evaluation.
Our initial consultations are always free, and there is no obligation to work with our team on your case. If you decide to let us handle your lawsuit, we will agree to do so on a contingency basis. This means you will not pay any upfront costs, so don’t hesitate to contact us now for help.
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