Heartburn sufferers may need to reconsider their go-to medications – both prescription and over-the-counter – in light of an April 1 announcement from the U.S. Food and Drug Administration (FDA) that it has issued a mandatory recall of all prescription and over-the-counter (OTC) drugs containing ranitidine from the market immediately.
Ranitidine – listed as an “H2 blocker” class medicine – decreases the amount of acid made in the stomach and is used to treat ulcers; gastroesophageal reflux disease (GERD), and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter ranitidine products are used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach.
“Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA,” the FDA commented.
“We heard the FDA was initiating it late last week. We've been working to get in touch with patient's doctors to switch them to a similar medication,” said Clint Sanders with Sanders Drugs in Toccoa. “I believe the health risk is pretty low, but it's probably best for people to stop taking it and get on another acid reflux medication. One of the potentially carcinogenic contaminants that prompted earlier recalls on specific batches was more widespread than originally believed,” he told ConnectLocal this morning, April 6.
“This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has 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,” stated the April 1 release from the FDA. “As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.”
“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 announcement stated.
The most widely-used OTC medicines containing ranitidine are Zantac products, as well as generic versions of the medication sold at many chain pharmaceutical stores such as Walmart, Walgreens and CVS.
“To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec),” stated the FDA announcement.
In September 2019, the FDA issued a warning that it had detected low levels of a cancer-causing chemical in samples of ranitidine. Some pharmacy chains, such as Walgreens, Rite Aid and CVS voluntarily removed some OTC medications from their shelves following that FDA warning. Also, some pharmaceutical companies that manufacture drugs containing ranitidine voluntarily recalled their medications in January.
NDMA has also been detected in several blood pressure medications.
“Since July 2018, the FDA has been investigating NDMA in certain blood pressure and heart failure medicines categorized as angiotensin II receptor blockers,” according to a Healthline article. “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.”
“In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home,” the FDA advised.