·  Legal News, Analysis, & Commentary

Recalls & Safety Alerts

The Attack on Zantac: Why Pharmacies are Pulling this Product

— October 4, 2019

Pharmacies and retailers are pulling heartburn medications from their shelves after cancer scare.

The Food and Drug Administration (FDA) recently warned that it had detected low levels of a chemical carcinogen in samples of Zantac and well-known pharmacies are pulling the product from their shelves.  Zantac has been widely used to treat stomach ulcers, gastroesophageal reflux disease (GERD), and heartburn.  The drug behind the branding is ranitidine, a histamine blocker that works to lower stomach acid levels, and all generic versions have also been pulled.

The pharmacies of Walgreens, Rite Aid and CVS have voluntarily removed the heartburn medicine from their inventory, and Walmart has also joined in.  A Walgreens spokesperson said the chain opted to pull the product “while the FDA continues its review of the products.” A Rite Aid spokesperson indicated it was “in the process of removing Zantac and generic versions sold under the Rite Aid name from its shelves.”  Walgreens and CVS are offering refunds to those who purchased the drug.

The Attack on Zantac: Why Pharmacies are Pulling this Product
Photo by VanveenJF on Unsplash

The FDA is recommending that anyone who relies on Zantac for relief contact their doctor to find a suitable replacement or find one availabel over-the-counter at these pharmacies.  The agency is still looking into the source of the contamination.  The agency’s warning reads, in part: “The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.  NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables…The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year…The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients…Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health.  Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

Some consumers expressed concern regarding taking the product while pregnant.  It falls under the FDA category B, meaning studies have shown Zantac is not harmful to a developing fetus, and the drug is the most commonly prescribed medication for expecting mother who experience acid reflux.  Luckily, physicians are saying that pregnant women would have to have taken large doses of ranitidine for an extended period of time to be at risk of developing side effects.

“For this to really affect you, you have to take huge amounts over a long period of time,” explained Dr. Jill Hechtman, an OBGYN at Brandon Regional Hospital. “This isn’t like, ‘Oh my God, I took Zantac for three weeks during pregnancy, I’m going to develop cancer.”  Hechtman recommends switching to a similar medication such as Pepcid, Prilosec, or Tums.

This month, the drug maker Novartis said that its generic-drug division, Sandoz, had stopped distributing a prescription form of ranitidine, and GlaxoSmithKline has also followed suit.


Zantac Pulled From Shelves by Walgreens, Rite Aid and CVS Over Carcinogen Fears

Walmart suspends sale of Zantac, other products containing ranitidine over cancer risk

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

Zantac panic: Is it safe for pregnant women to take?

Join the conversation!