Lawsuit Mania: FDA Recalls Zantac & Here’s Why

You might have heard of Zantac lawsuits floating on the news these days, or maybe you have noticed that Zantac and other ranitidine products are unavailable in stores. These sudden events have risen because of the recently found discovery about the drug.

Last year, Zantac was withdrawn from the markets. It may have come as a surprise to people for a commonly prescribed and used drug to be recalled. FDA requested the recall of Zantac and other ranitidine products because of the health hazards they pose to the public

Here are some background stories and details behind the Zantac recall.

Zantac

Zantac or also called by its generic name ranitidine is a histamine H2-receptor antagonist or commonly known as an H2 blocker. It is what you would call an antacid. It prevents the build-up of acidity in your stomach. It is widely used to treat gastrointestinal issues like heartburns, acid reflux, ulcers, and gastroesophageal reflux disease (GERD), to name a few.

It was initially owned and invented by GlaxoSmithKline or GSK. GSK’s patent for ranitidine expired in the late 90s, after which Pfizer got the FDA approval to sell it in the early 2000s. In 2006, Boehringer Ingelheim bought it from Pfizer. Sanofi acquired Zantac in 2016 and is still the current manufacturer.

Zantac is a famous drug. It is honored to be one of the best-selling drugs in pharmaceutical history – reaching billions of dollars in annual sales. The drug had successful marketing because of its effectiveness; it was safe to use, or so they say. 

New Discovery

For more than four decades, Zantac has been one of the top drugs prescribed by doctors for patients. When people have ulcers or heartburns, they always rely on and buy ranitidine to ease their conditions. 

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No one is contending the effectiveness and efficiency of the drug. However, there have been recent studies that show Zantac with off-the-chart NDMA levels. It is reported to be dangerous for patients. 

During the second and third quarters of the year 2019, an analytical pharmacy that tests drugs in the market called Valisure has conducted a Zantac test. The result shows that it has high levels of NDMA. According to their findings, a tablet contained 2,511,469 ng of NDMA.  

NDMA or N-Nitrosodimethylamine is a toxic chemical harmful to humans, especially when exposed to high levels. It is considered a carcinogen, a substance that can cause cancer. Based on the World Health Organization (WHO), NDMA is a carcinogenic agent that increases the risk of developing gastric and colorectal cancers. 

Other studies conducted by other institutions like Standford University agree with Valisure’s. They also found NDMA levels that exceed the acceptable daily intake.  Due to these horrific findings, Valisure immediately filed a citizen petition to the FDA, sharing their research with the authorities. 

In September 2019, the FDA administered their test, and their initial findings revealed that there were traces of NDMA in Zantac tablets. However, they were not that high as the results of Valisure’s test. 

There were speculations that the FDA’s test was flawed. But the FDA defended their findings and explained that the high-level NMDA result was because of the high heat used in the testing method. Therefore, it does not portray the usual conditions that the medication would be exposed to. 

Nonetheless, they have expressed their concerns for public health safety. They agree that even under normal conditions, the traces of NDMA was higher than expected. 

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Further studies and tests were administered. They learned that exposure to high temperatures increases the level of NDMA. They saw that the older drug batches have higher levels as well. 

What prompted this discovery is the earlier detection of NDMA in another drug. Last 2018, Valisure also tested a batch of Valsartan, which is a blood-pressure drug. They found out that it was contaminated with NDMA. 

The Valsartan was said to be contaminated because of its flawed manufacturing process. Unlike it, the presence of NDMA in Zantac is caused by the product itself. It is caused by the instability and metabolization of the active component, ranitidine HCl. 

Recalls

With the considerable amount of scientific evidence presented against ranitidine, the FDA had to protect the public. They have pulled out the Zantac from the market and all other ranitidine medicine. 

During their initial test last September 2019, they announced the discovery of NDMA in Zantac and warned the public about the potential risks. They also suggested that patients should use alternatives. Since their announcement, several manufacturers voluntarily recalled their ranitidine products. 

Sandoz and Apotex, generic manufacturers of ranitidine, were the first to pull out their products. Zantac’s manufacturer, Sanofi, also followed suit. Other ranitidine manufacturers like Perrigo, Lannett, and Novitium recalled during the last quarter of 2019. Pharmacies and stores, like CVs and Walmart, also stopped selling the medication.

In January 2020, Emery Pharma filed a petition to the FDA to recall ranitidine from the markets and stop the sales. In April 2020, the FDA officially released a request to all manufacturers and stores to suspend the production and sale of ranitidine drugs. 

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Zantac Lawsuit

Ever since the FDA’s announcement about the high NDMA levels found in Zantac and generics, many Zantac users filed a lawsuit against Zantac manufacturers. They claimed that the manufacturers withheld this information from the public and that Zantac caused or aggravated their cancers. 

In November 2019, plaintiffs requested to form multidistrict litigation (MDL) to consolidate all lawsuits into one court. This motion was approved, and MDL No. 2924 was formed in February 2020. 

Currently, the number of cases under MDL No. 2942 is 562. The Zantac cancer lawsuit is still in its early stages. It is being processed in Florida by Judge Rosenberg. 

Although many discoveries were unfolded in just the second half of 2019, institutions are continuing their research about ranitidine to learn more about its effects and risks to the public. The events on Zantac and ranitidine run more profound than what is on the surface. It shocked the public as patients and doctors trusted this medication. 

The dangers this drug possessed caused the FDA and manufacturers to recall. Zantac is not for sale anymore. The FDA is encouraging people to stop using it, and those who still have this medication can turn them over to drug take-back locations or dispose of them according to the specific instructions.

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