- Sanofi is recalling the popular heartburn drug Zantac.
- The generic name for the drug is ranitidine.
- The medication may contain a cancer-causing chemical that’s already been detected in certain blood pressure medications.
- The Food and Drug Administration (FDA) is still investigating whether the chemical is at a high enough level to be a health risk.
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 pharmaceutical company Sanofi announced today that it’s undertaking a voluntary recall of Zantac due to concerns about a potential cancer-causing chemical.
This comes weeks after the popular heartburn drug ranitidine, known by the brand name Zantac, was found to contain a cancer-causing chemical. Last month, multiple drugstores decided to no longer sell the medication.
CVS and Walgreens no longer sell Zantac and other ranitidine medications.
CVS is currently offering customers who recently bought Zantac or another ranitidine drug a refund. The chain will continue to sell other over-the-counter (OTC) heartburn medications, like Pepcid and Tagamet, which don’t contain ranitidine.
Although Sanofi issued its recall today, other drug companies like Apotex Corp. and Sandoz Inc. announced last month that they’re voluntarily recalling all of their ranitidine-based products sold in the United States due to the risk.
In September, the FDA reported that small amounts of a cancer-causing chemical called N-nitrosodimethylamine (NDMA) were detected in several brand-name and generic heartburn medications.
Even though the FDA identified the carcinogen, the organization isn’t yet recommending people stop taking ranitidine products.
This affects the many people who regularly use ranitidine medications to prevent and treat heartburn, ulcers, and gastroesophageal reflux disease (GERD).
The FDA is investigating whether the low levels found in the ranitidine medicines create a health risk.
Once the FDA has that information, it’ll share it. But for now, the agency isn’t recommending people stop taking ranitidine.
“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,”
If you take a medication with ranitidine, you might want to consider opting for a different drug — though it’s not necessary at this time.
Cimetidine, known as Tagamet, and famotidine, or Pepcid, are two other types of OTC medications commonly used to treat heartburn and acid reflux.
If you have a prescription, your doctor can recommend another treatment option.
“While Zantac may prove safe in the long run, this latest statement adds confusion and concern, so my interim advice to patients is simple: Switch to another drug (there are other options), and of course confirm with your doctor the need for an antacid,” Dr. David Robbins, the associate chief of endoscopy at Lenox Hill Hospital, said in an earlier statement.
Dr. Linda Nguyen, a gastroenterologist at Stanford Health Care in California, has similar advice.
“According to the FDA alert, the issue does not appear to be related to the drug class but due to contaminants specific to ranitidine,” Nguyen told Healthline in an earlier interview.
“Ranitidine is an H2 (histamine-2) blocker that decreases the acidity in the stomach. It is frequently used for heartburn and dyspepsia (stomach upset or indigestion). Ranitidine is available over the counter and [by] prescription. There are alternative H2 blockers available in the U.S., including famotidine (Pepcid) or cimetidine (Tagamet). Patients should consult with their clinician or pharmacist for equivalent dose conversions,” Nguyen said.
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
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 last year, the FDA has been investigating NDMA in certain blood pressure and heart failure medicines categorized as angiotensin II receptor blockers.
In July, the agency issued a handful of
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.
The FDA stressed the importance of continuing to take the medications until a healthcare provider could recommend a replacement.
If you experience any side effects after taking these blood pressure medications or any heartburn medications with ranitidine, report it to the FDA’s
The pharmaceutical company Sanofi is voluntarily recalling its heartburn medication Zantac.
The news comes weeks after the FDA announced that ranitidine heartburn medications may contain traces of a cancer-causing chemical known as N-nitrosodimethylamine (NDMA).
The agency is currently looking into the health risks associated with the amount of NDMA identified in the drugs. It will post more information as it learns more.
As of now, the FDA isn’t recommending people stop taking ranitidine, but those who’d like to switch medications should talk to their doctor about other treatment options.