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FDA officials told companies that manufacture ranitidine medications sold under the name Zantac to remove their product from the market. Getty Images
  • Officials at the Food and Drug Administration (FDA) have ordered all ranitidine medications, sold under the brand name Zantac, taken off store shelves immediately.
  • The order is tied to concerns that the medication may contain a cancer-causing chemical that’s also been detected in certain blood pressure medications.
  • A voluntary recall was implemented by companies in January, but FDA officials say there is evidence the impurity in the cancer-causing chemicals in Zantac may increase over time.

Editor’s note: This is a developing story that’s been updated since it was first published. Healthline will continue to update this article when there’s new information.

The heartburn and ulcer medication Zantac is being taken off store shelves as concerns increase over cancer-causing ingredients.

Officials at the Food and Drug Administration (FDA) issued the order today to immediately remove from the market all prescription and over-the-counter (OTC) ranitidine medications sold under the brand name Zantac.

A voluntary recall of these medications had been implemented by two companies in January after the FDA detected the cancer-causing chemical N-nitrosodimethylamine (NDMA) in several brand name and generic heartburn medications.

On Wednesday, FDA officials said they are issuing the mandatory recall because they have “determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”

The FDA officials said they have sent letters to drug manufacturers “requesting they withdraw their products from the market.”

“The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products,” the agency said.

In January, the FDA had announced that two companies were voluntarily recalling their ranitidine medications.

  • Appco Pharma LLC voluntarily recalled prescription ranitidine hydrochloride capsules.
  • Northwind Pharmaceuticals voluntarily recalled prescription ranitidine tablets (150 milligrams and 300 mg), manufactured by Glenmark Pharmaceutical Inc.

In October, pharmaceutical company Sanofi announced it was undertaking a voluntary recall of Zantac due to the concerns about the potential cancer-causing chemical.

Last year, a number of drug stores stopped selling the drug. CVS and Walgreens no longer sell Zantac and other ranitidine medications.

CVS offered customers who had recently bought Zantac or another ranitidine drug a refund.

The chain continues to sell other over-the-counter (OTC) heartburn medications such as Pepcid and Tagamet that don’t contain ranitidine.

In September, the FDA reported that small amounts of NDMA were detected in several brand-name and generic heartburn medications.

This affects the many people who regularly use ranitidine medications to prevent and treat heartburn, ulcers, and gastroesophageal reflux disease (GERD).

The FDA started to investigate whether the low levels found in the ranitidine medicines create a health risk.

“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,” Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement at the time.

NDMA is an environmental contaminant found in water along with meat, dairy, and vegetables.

It’s classified as a B2 carcinogen, meaning it’s a probable human carcinogen. Exposure to high amounts of NDMA is thought to cause gastric or colorectal cancer, according to the World Health Organization.

It’s extremely toxic to the liver. Even small amounts may be linked to liver damage.

The chemical was once used to make rocket fuel. Today the chemical is only used for research purposes in the United States, according to the Environmental Protection Agency.

It’s also a byproduct of many manufacturing processes at industrial sites, including tanneries, pesticide manufacturing plants, and rubber and tire manufacturers.

The chlorination of drinking and wastewater, which treatment plants do to purify our water, can unintentionally create NDMA as well.

Since July 2018, the FDA has been investigating NDMA in certain blood pressure and heart failure medicines categorized as angiotensin II receptor blockers.

The agency issued a handful of recalls of blood pressure medications after a concerning amount of NDMA was found in the drugs valsartan, losartan, and irbesartan.

The FDA estimated that if 8,000 people took the highest dose of the recalled valsartan daily for 4 years, there’d be just one additional cancer case from that group of people.

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