The US Food and Drug Administration (FDA) recently ordered the popular heartburn medicine, Zantac, to be taken off the market. Pharmacies are removing the OTC medicine from shelves while doctors are no longer prescribing the medicine to patients.
This development comes from six months of monitoring and research when there was an indication that Zantac and the generic versions could contain a potential carcinogen. At that time, many well-known pharmacies, such as CVS and Walgreens, removed the product voluntarily because of concern. Now, the FDA stands behind this decision and has any remaining pharmacies that still sell the drug to stop immediately. Ranitidine is the active ingredient in these medications.
The concern with ranitidine is that it contains N-Nitrosodimethylamine (NDMA), which is a potential carcinogen. NDMA is found in other sources, such as cured meats and drinking water. However, the amount allowed is regulated by the government. The amount determined to be in Zantac could be above what is allowed by federal regulations.
The FDA doesn’t place blame on the manufacturing process. Instead, it appears that the ingredient can degrade into NDMA just from sitting in storage. The longer the substance is stored, the more likely it would contain higher amounts of NDMA. Further testing indicates it could continue to break down once it has been made into tablet form or even after it had been taken by the patient.
NDMA can be broken down by the liver and be removed from the system. A person can be exposed to the chemical in several ways, including through shampoos, cigarette smoke, pesticides, malt beverages and when manufacturing tires. Most of the time, the amount of exposure is below the legal limit.
Testing on animals shows an increase in liver cancer as well as cancer of the kidneys, respiratory tract and blood vessels. It has led to internal bleeding and even death in animals.
Anyone who has been taking Zantac or its generic versions should stop right away. A recall has been initiated in the US and Canada for the product. People can switch to other medications that treat heartburn. If a person has been taking the prescription version, they should talk to their doctor about other options.
According to the FDA, no NDMA has been found in other medications, like Pepcid, Prevacid and Prilosec. Zantac has been popular for use in patients with gastroesophageal reflux, which occurs when the acid in the stomach goes back up into the esophagus, causing heartburn. It has also been prescribed in people who make too much stomach acid because it blocks the formation of acid.
A person may not be diagnosed with cancer right away, but the danger increases if the person takes Zantac over a long period of time, which is common in people with chronic heartburn. If they are exposed to NDMA through other sources as well, it increases their risk. It’s important to take this risk seriously and stop the medication to prevent long-term effects.