For parents whose babies have been prescribed Zantac syrup for reflux or mothers who have taken over-the-counter Zantac pills to help with pregnancy heartburn, recent headlines about the drug are understandably concerning.
Earlier this month the FDA made a statement alerting patients and health care providers to the presence of an impurity called N-nitrosodimethylamine (NDMA) at low levels in the heartburn drug Zantac and the generic version, ranitidine. The FDA is concerned because “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.”
This is important information, but don’t panic, mama. Experts say consumers need to be informed but there is not an immediate health concern.
Here’s what you need to know and do if you or your baby is taking Zantac:
1) Call your doctor
The FDA, Health Canada and European regulators all share concerns about ranitidine, which is commonly known as Zantac and sold as an over-the-counter pill for adults, and as a prescription syrup for pediatric patients, including infants. Animal studies classified NDMA as a probable carcinogen, meaning long-term use could pose a cancer risk.
If you or your child have been using it, call your doctor and discuss alternatives. The FDA “is not recommending individuals stop taking all ranitidine medicines at this time,” but suggest that “patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options.”
2) Don’t panic
Regulators, retailers and medical professionals are working to protect patients. The alarm bell has been raised. In Canada and parts of Europe, health agencies pulled the medication from all store shelves, and in the United States, retailers are taking action to voluntarily follow suit, pulling medications from store shelves.
On Saturday CVS announced it suspended sales of all ranitidine products “Zantac brand products and CVS brand ranitidine products have not been recalled, and the FDA is not recommending that patients stop taking ranitidine at this time. However, customers who purchased these products can return them to CVS for a refund,” the company said it a statement.
Bottom line: The FDA has not received any reports of adverse events caused by NDMA in ranitidine, but regulators have reason to be concerned.
However, parents who have taken the drug or given it to their children should not freak out. “It is important to know that the NDMA in ranitidine products does not pose any immediate health risks,” Joshua J Gagne, PharmD, ScD is an Associate Professor of Medicine at Brigham and Women’s Hospital and Harvard Medical School, writes for Harvard Health.
He continues: “Although classified as a probable carcinogen, NDMA may cause cancer only after exposure to high doses over a long period of time.”
If you have concerns about Zantac, call your doctor.