A carcinogen is a substance or material capable of causing cancer.
Roughly six months ago, drug manufacturers began recalling Zantac (ranitidine) heartburn medications. This month, the U.S. Food and Drug Administration (FDA) requested all Zantac products be pulled from the market. This request includes all prescription and over-the-counter (OTC) Zantac products.
What is causing all this turmoil over a heartburn drug? A cancer-causing impurity was found in the drug. The impurity prompted both the earlier recalls and the FDA's market withdrawal request.
The Initial Zantac Recalls
In June 2019, Valisure -- an independent online pharmacy -- found a cancer-causing substance in some ranitidine-containing products. The company filed a citizen petition to the FDA calling for action. Thus, the FDA's investigation into Zantac began. The FDA did not come to the same initial conclusions as Valisure. However, the agency's initial test results did find unsafe levels of the carcinogen in some forms of the drug.
The carcinogen in question is n-nitrosodimethylamine (NDMA). The FDA's investigation next turned to how the substance came to be in the heartburn drug. During this time, manufacturers began recalling Zantac products. Some were recalled after testing positive for unsafe levels of NDMA. Others were recalled as a precautionary measure.
NDMA & Blood Pressure Medications
Zantac is not the first drug contaminated by NDMA. In July 2018, the FDA announced the first recall of valsartan medications over concerns of NDMA contamination. Valsartan is a common blood pressure medication. Manufacturers recalled several other blood pressure medications for similar contaminations during the year.
Learn more about NDMA, the potential cancer risk, and the drugs it's affected >>>
The Root of the Contamination
Initially, Valisure hypothesized NDMA resulted from a chemical reaction. Through testing, the online pharmacy found that heated ranitidine could release NDMA. The company claimed this same chemical reaction could take place in a patient's stomach. This meant Zantac carried a risk of cancer, and patients were unaware.
The FDA was not convinced of this initial theory. However, recent findings in the investigation have changed the agency's stance.
The FDA's Latest Action
On April 1, 2020, the FDA issued a press release. In the press release, the agency requested a market withdrawal of all ranitidine medications. According to the FDA, levels of NDMA in ranitidine medications increase through two methods:
- Time - As ranitidine products break down in normal storage conditions, NDMA production increases.
- Heat - When ranitidine products are heated higher than room temperatures, NDMA production increases.
The FDA requested all Zantac products be pulled from shelves after this discovery. According to the agency, there is no surefire way to tell how long the products have been stored. Therefore the safest course of action is to halt the sale of all ranitidine-based products.
We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.FDA Press Release
How This Impacts Consumers
The market withdrawal will remove all Zantac products from pharmacy shelves going forward. As the FDA's press release explains, "...ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S." Consumers who use Zantac must find an alternative medication to treat their condition.
Consumers Using OTC Zantac
The FDA advises consumers who use OTC Zantac to stop taking the drug immediately. Consumers should find an alternative medication or treatment method. Additionally, the FDA advises consumers to dispose of any Zantac products properly.
Consumers Using Prescription Zantac
Consumers taking prescription Zantac are advised to stop taking Zantac. However, patients should consult their doctor about an alternative treatment method before making changes.
Consumers Filing Zantac Lawsuits
Since the initial recall, consumers have been filing lawsuits against Zantac manufacturers. The lawsuits claim drug manufacturers failed to warn consumers about an established scientific link between ranitidine and NDMA. Valisure cited this link in the company's initial research on the topic. The FDA's decision to pull all Zantac products off the market may lead to an increase in Zantac lawsuits.
It's also important for consumers to share this information. This market withdrawal is in no way related to the COVID-19 pandemic, but it is still affected by the crisis. Stories of the pandemic currently dominate the news. As a result of this, information about lesser health issues may spread more slowly.
Share this information with family, friends, and neighbors (from a distance of six feet or virtually). By doing so, you can help ensure the health and safety of thousands of Americans.