On April 1st, 2020, the Food and Drug Administration (FDA) recalled all over-the-counter (OTC) Zantac ranitidine drugs over risks of cancer. The FDA requsted both ranitidine and Zantac pulled from shelves as they contain N-Nitrosodimethylamine (NDMA), a cancer causing agent.
The FDA warned NDMA was increasing over time in the medication, meaning the drug was getting more and more contaminated over time as it sat waiting to be shipped, purchased, and consumed by consumers. With the NDMA in Zantac increasing over time, testing of product either in the distribution channel or on store shelves may not be capturing all the risk taken when it is slowly consumed at home.
The FDA recommends you dispose of existing Zantac or ranitidine, and not purchase more if retailers have failed to removed it from shelves. Those with conditions Zantac treats are being recommended to switch to another drug type.
Zantac is the name brand of a drug to treat and prevent heartburn and other conditions. The drug, an H2 antagonist, works by reducing acid through reducing the amoung of acid your body produces. Zantac uses include treatment of ulcers and gastroesophageal reflux (GERD).
Generic Zantac goes by the name ranitadine. Zantac NDMA contamination is occurring in all forms of Zantac, branded and generic, and all are subject to the recall request by the FDA.
Zantac has been associated with these cancers:
If your toddler has testicular cancer and you ingested Zantac or ranitidine during your pregnancy, this cancer may be associated with the use of the medication as a cause.
The FDA warned in September 2019 that Zantac may cause toddlers to develop testicular cancer. Common forms of testicular cancer in boys include a yolk sac tumor, teratoma, or germ cell tumor.
On September 9, 2019, Valisure released a citizen petition calling on further testing and recall of all ranitidine products including Zantac due to NDMA contamination.
NDMA and similar cancer causing nitrosamine contaminants were already in the news, after other drugs such as Valsartan were discovered to contain NDMA. Other nitrosamine chemicals include N-Nitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
The presence of NDMA and other nitrosamine chemicals had already caused the recall of many lots of Valsartan, and Valisure released new data showing similar NDMA issues with Zantac.
First, generic Zantac is not sold as Zantac. The active drug ranitadine can be resold under many different store brand names. The companies manufacturing ranitidine include:
The store names of ranitidine that are recalled include:
Valisure tested drugs sourced from multiple manufacturers and stores, and found NDMA per tablet ranging from 2.5million ng to 3.27million ng per tablet. These levels are far above what is expected and acceptable as a risk from a heartburn over-the-counter medication.
The FDA 2019 warnings include the September 13, 2019 statement alerting patients and doctors about NDMA in ranitidine, the September 26, 2019 statement on recalls of some ranitidine medication in the United States, another October 28, 2019 update regarding more recalls, and a November 1st, 2019 update on laboratory testing results for NDMA in raitidine.
To read all of the FDA updates, see the FDA website dedicated to listing all of these updates in one location: FDA Zantac Ranitidine Update Page.
In January and Feburary of 2020, additional recalls of Zantac ranitidine medication occurred.
As noted previously, on April 1st 2020 the FDA initiated a Zantac recall for all medication in the United States, including generic variations. The FDA warned consumers to avoid taking any remaining pills, and to dispose of the medication safety instead.
All versions containing the same active ingredient in Zantac, ranitidine, are recalled regardless of what manufacturer made it or what name it was sold under. Patients are directed to switch to another heart burn or GERD medication. It is rare for an FDA recall to request patients stop taking medication.
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