Zantac: Overview Of Recall And Lawsuits Due To Cancer-Causing NDMA

Zantac: Overview Of Recall And Lawsuits Due To Cancer-Causing NDMA

February 28, 2020

Many people turn to Zantac when they suffer from heartburn. It’s been a go-to medication because it was seen as safe and no prescription was necessary.

Potentially millions of people have turned to Zantac over the years because of its effectiveness, it’s affordable cost, and the perception of it being a safe solution. That all changed with a report from the FDA to identify that the drug may contain N-Nitrosodimethylamine (NDMA), which is a substance that is likely to cause cancer.

There have been mass voluntary recalls over the past several months as well as various updates and reports from the FDA regarding the dangers of taking Zantac. Consumers need to be aware of the possible dangers of taking this medication for their heartburn.

At Allan Berger & Associates, we are here to help you with a Zantac lawsuit if you or a loved one has experienced any complicated side effects or have had a cancer diagnosis.

Understanding Zantac

Zantac is the brand name that belongs to Sanofi. The product is ranitidine, an H2 histamine receptor antagonist. Essentially, it is an antacid that reduces the amount of stomach acid being produced by your body. Most people turn to Zantac as a way to treat heartburn, acid reflux, and ulcers.

Understanding NDMA

NDMA, the drug that may be found inside of Zantac, is a possible carcinogen. It’s important to understand that it is not the same active ingredient found in ecstasy, which is MDMA.

The FDA considers NDMA to be a “probable” carcinogen as it has led to creating cancer in laboratory animals. It may not be harmful in small doses as it is also found in a number of cured and grilled meats. With sufficient exposure, NDMA may cause cancer in humans, including in the stomach and bladder. It may also be damaging to the liver.

The Quantity of NDMA in Zantac

The first instance of NDMA causing cancer was published by the Citizen Petition produced by Valisure and sent the FDA in September 2019. According to the petition, it was explained that testing resulted in identifying all alarming levels of NDMA in ranitidine, the base product of Zantac.

The FDA identifies that humans are able to safely consume up to 96 ng of NDMA on a daily basis. The reports tested a variety of over-the-counter hundred and 50 mg ranitidine medications found that various drugstores. In each dose, there was between 2.2 and 3.2 million ng. This demonstrated that taking a single 150 mg pill on a daily basis meant that a person was potentially consuming up to 30,000 times the amount of NDMA that the FDA identifies as being acceptable.

When Valisure tests were modified to simulate the human body, the report still showed that the 150 mg pill contained between 23,600 and 304,500 ng of NDMA.

Perhaps the biggest problem is that the ranitidine testing results produced by the FDA show far lower levels than the study completed by Valisure. While the levels were elevated in the FDA studies, it wasn’t alarming enough for them to stop the sale of ranitidine.

How the FDA is Dealing with Zantac

The FDA is not taking a very strong stance with Zantac as of yet. They have issued press releases, statements, and updates to the public. They have completed their own ranitidine testing and have asked manufacturers to test for NDMA prior to products going to store shelves.

The FDA alerted the general public in November 2019 about a voluntary recall for rented on medications that were manufactured by Aurobindo Pharma USA. In December 2019, they asked manufacturers to test for ranitidine prior to shipping to retailers. Later in December, another voluntary recall was issued by Glenmark Pharmaceuticals. Another one was followed in January 2020 from Appco Pharma LLC as well as Northwind Pharmaceuticals.

The Start of Zantac Lawsuits

Zantac has been a very popular product on the market throughout the United States. This leads to the notion that there will be a significant amount of litigation against ranitidine companies. Although many pharmaceutical companies have already established voluntary recalls, Sanofi, the company behind Zantac, has not been one of them as of yet. Further, the number of lawsuits being seen are almost entirely against Sanofi.

The majority of the lawsuits are not focusing on the presence of cancer or other personal injuries due to the presence of NDMA. Instead, the lawsuits focus on consumer fraud, a breach of implied and express warranties as well as unfair competition laws.

It will only be a matter of time before personal injury class-action lawsuits begin. If you or someone you know has been diagnosed with stomach or liver cancer and has a history of taking Zantac, you should call our offices in order to schedule a consultation.

Personal injury class-action lawsuits are more comprehensive because it’s easier for plaintiffs to claim that the defendant (the pharmaceutical company) deceived them by not identifying health risks as opposed to saying that the ranitidine caused cancer.

Cancer is a comprehensive disease and plaintiffs must identify how much ranitidine was consumed in order to cause cancer. It isn’t an impossible case to prove, but it will take time to build properly.

The Future of Zantac

With so many new developments taking place over Zantac and all of the other medications that contain ranitidine, it will take time for personal injury lawsuits to be created against the various distributors. There is a possibility of massive litigation. On an annual basis from 2007 to 2017, ranitidine was prescribed approximately 15 million times in the United States alone. This doesn’t account for over-the-counter sales, either.

It is possible that multi-district litigation will take place at some point as more lawsuits get filed. This can lead to more efficient litigation as well as the potential for a settlement to avoid courts for decades into the future.

At this point in time, if you or someone you know is taking ranitidine, it’s best to avoid taking it. Speak to your doctor first to address your concerns to find out if there is another product on the market that can work similarly as an antacid without containing this potentially cancer-causing ingredient.

If you have questions or are worried about the potential impact taking Zantac has had on your health contact one of our litigation specialists at Allan Berger & Associates.

By |2020-05-08T18:15:06+00:00February 28th, 2020|Product Liability, Drug Injury|

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