Ranitidine Cancer Concerns: What Users of Zantac & Generics Need to Know

In mid-September, the United States Food & Drug Administration (FDA) issued a warning to the public that a known environmental contaminant and probable human carcinogen had been detected in some formulations of ranitidine, including Zantac® and other generic label products. Ranitidine is a popular over-the-counter drug used to treat heartburn.

Because heartburn is a common condition, it’s no surprise that many people were alarmed by the FDA’s announcement. After all, many Americans experience heartburn-related discomfort from time to time, and many seek out some kind of medication to find relief.

Over the past few weeks, concern over the FDA’s statement has grown, with several large pharmacy chains electing to pull Zantac and its generic ranitidine equivalents from their shelves voluntarily.

This, of course, has in turn led to even more concern and more confusion among patients who use the drug for heartburn relief.

What is ranitidine?

While Zantac is the name that keeps getting mentioned in the news, the actual name of the drug that led to the FDA statement is ranitidine; Zantac is merely a brand of ranitidine, similar to how most people know acetaminophen as Tylenol.

Ranitidine is a histamine-2 antagonist, more commonly known as an H2 blocker. At a basic level, H2 blockers work by lowering the amount of acid produced by the stomach. This in turn helps to ease the symptoms of heartburn, which is caused by stomach acid building up into the esophagus.

While prescription-strength doses do exist, ranitidine is an over-the-counter (OTC) drug, meaning it doesn’t require a prescription.

Zantac may be the most popular brand of ranitidine on the market, but other drug manufacturers make and distribute ranitidine, which retailers then sell as their own generic, store-brand products.

Why is there concern over ranitidine?

The issue that led to the FDA’s initial statement surrounds a compound called NDMA, which the FDA calls a “known environmental contaminant.”

NDMA is dangerous because it’s considered a probable human carcinogen, which means it’s a compound that could cause cancer.

If the term NDMA seems familiar, it may be because NDMA is one of the impurities that led to a large-scale recall of certain blood pressure medications a little more than a year ago.

According to the FDA, recent laboratory tests found low levels of NDMA in some ranitidine products. While the FDA stated that the levels of NDMA found in these ranitidine products “barely exceed” what one might find in some common foods, the idea that a widely used drug contains a compound that may cause cancer is certainly going to be troubling for the average ranitidine user.

The original issue with NDMA being found in ranitidine products was actually reported to the FDA by a third-party pharmacy and laboratory.

However, in an Oct. 2 update on the matter, the FDA stated that early testing that the agency conducted on its own also found “unacceptable levels of NDMA in samples of ranitidine.”

Has there been a ranitidine recall?

As of early October, the FDA had not issued a mandatory recall for Zantac or generic ranitidine medications. Currently, the FDA is testing a variety of different ranitidine products and working to determine how the potential presence of NDMA has affected ranitidine users.

However, if you’ve heard a family member or neighbor talk about a “Zantac recall,” it may be due to the fact that several large pharmacy chains have voluntarily stopped selling Zantac and generic ranitidine products.

CVS, Walgreens, Rite Aid, and Wal-Mart have all elected to stop selling ranitidine products while the FDA conducts its investigation.

These stores have decided to stop selling both Zantac and their own generic ranitidine products. While these stores are allowed to make their own business decisions, it’s worth noting that an official recall notice has not yet been issued by the FDA.

Should I stop taking Zantac?

As mentioned above, there’s been no official ranitidine recall issued by the FDA. Instead, the FDA is looking into these findings out of an abundance of caution. Any drug that has the potential to cause cancer should be investigated, and the FDA is doing its due diligence.

However for every FDA action, there’s going to be a public reaction, and most users of Zantac and other ranitidine products are going to be understandably alarmed. As heartburn is a common condition, there are some users who likely take Zantac or other ranitidine products with some degree of frequency, and will likely seek other options for heartburn relief.

If you are taking a ranitidine product as ordered by your doctor, it’s best to check with that doctor before switching from ranitidine to an alternative.

What are the alternatives to Zantac?

Fortunately for most ranitidine users, there are several other heartburn treatment options on the market that do not feature ranitidine as an active ingredient.

Patients who would like to stop taking ranitidine but still need relief from heartburn should consider other OTC medications like Pepcid® (famotidine), Prilosec OTC® (omeprazole), or even calcium carbonate chews.

Ask your pharmacist for input

If you’re currently taking other medications, you should ask your local pharmacist for advice before making a purchase.

Pharmacists are trained to have medication counseling conversations with patients.

Your pharmacist will be able to ensure that the new product you’re choosing for heartburn relief isn’t going to have negative interactions with your other medication.

For some patients, diet management can be an effective alternative to medication for heartburn as well. Try to identify the foods or drinks that are causing your heartburn, and consider seeking out alternatives to those foods.

Kristopher Young, PharmD, is the Chief Pharmacy Officer and Executive Director, Pharmacy, Laboratory and Clinical Nutrition Services at South Shore Health.

Nicole Allie, PharmD, BCGP, and Clinical Pharmacy Specialist at South Shore Medical Center, contributed to this post.