Zantac Recall Linked to Cancer Risk

This page features: Cited Research Articles

On April 1, 2020, The FDA ordered all prescription and over-the-counter ranitidine drugs, most commonly known as Zantac, pulled from the market immediately.  Patients are strongly advised by the FDA to cease using any Zantac currently in their possession and to consult with their physician on finding another treatment option.

Once a household name, Zantac has been used by millions globally over decades in the treatment of heartburn and gastroesophageal reflux disease commonly referred to as GERD.  The prescription drug is also commonly used to treat stomach ulcers.

As reported in U.S. News and World Report, “Today’s action requesting companies to withdraw all remaining ranitidine products the U.S. market is being taken out of an abundance of caution,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an agency news briefing on Wednesday.

The FDA began investigating Zantac after Valisure, an online pharmacy based in Connecticut, reported the danger of the common prescription drug.  During a routine analysis of drug products in their pharmacy, the CEO of Valisure David Light discovered and promptly reported that ranitidine drugs can degrade and form NDMA.

After the online pharmacy appealed to the FDA to recall the dangerous drug, the government agency initially hesitated, given that Valisure only noted the dangerous levels of NDMA after heating the product. Still, on September 24, 2019 the FDA issued a voluntary recall of ranitidine drugs, citing the presence of a nitrosamine impurity.

Following the FDA announcement, retailers including CVS, Walgreens and Walmart stripped the Zantac from their shelves, and stopped filling prescriptions of the drug.  

Zantac has made the news for cancer-related concerns in the past, with this most recent issue regarding the danger of the ranitidine drug, given the rising levels of N-Nitrosodimethylamine (NDMA). After investigating the concern raised by Valisure, The FDA discovered that ranitidine is unstable, with the dangerous increase in NDMA occurring after the drug is incorrectly stored.

NDMA is a contaminant – a type of nitrosamine widely believed to be carcinogenic in humans.  Nitrosamine is the carcinogen in smoked or grilled meats, especially bacon, along with beer, cheeses and some fish.   

Heat causes the probable cancer-causing NDMA to accumulate in Zantac, with storage temperature being investigated as the root of the problem.  Another issue being investigated is how NDMA accumulates when the prescription is stored for too long. 

In fact, FDA tests found that the older the ranitidine is, the higher the amount of NDMA climbed in the product.  And while low levels of NDMA has not been found to be harmful in humans, the higher levels found in old and/or incorrectly stored ranitidine based products are widely considered cancer-causing.

According to the World Health Organization (WHO) the organs potentially affected by NDMA include the lungs, kidneys, liver, brain, bladder and stomach.  

Due to the COVID-19 global pandemic, the FDA advises not dropping the Zantac to a drug take-back location.  Instead, patients can follow the safe disposal instructions from the pharmacist, or visit the agency’s website.

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