Why Was Zantac Taken Off the Market?

shopping for medicine 100x100 1

A close up of a woman with an empty shopping basket looking at the shelves of medicationZantac has been pulled from store shelves by the FDA because of its link to a probable human carcinogen, known as N-nitrosodimethylamine (NDMA). This requirement comes after investigations into the effect of long-term storage and hot temperatures on the medication: The levels of the chemical NDMA increase over time, and significantly when heated (such as may occur if the box of medication was left in a hot car on a summer day, for example).

NDMA is the same chemical found at low, acceptable levels in water and certain foods, especially cured meats, which have also been linked to cancer.

The generic name for Zantac is ranitidine. This heartburn medication is taken by roughly 2 million Americans, according to a CBS News report.

In September, 2019, the FDA issued a warning to the public concerning ranitidine when research showed high levels of NDMA. As a result, voluntary recalls were issued and an FDA investigation was initiated. According to CBS, that research included this startling finding: When stored for 12 days at room temperature, a dose of ranitidine increased to 25ng of NDMA, which is actually lower than the limit accepted as safe by the FDA of 96ng. When heated to 158 degrees Fahrenheit, NDMA rose to 142ng in the same dose. This is far above any acceptable standard. Researchers concluded that the likely carcinogen was being formed in the drug when exposed to heat.

On April 1, health regulators ordered a mandatory recall of all prescription and over-the-counter versions of ranitidine. The agency concluded the risk to the public is too great because NDMA can increase over time, while the medication is being transported or stored. The FDA advises the public to throw out any OTC Zantac products still in their possession; discontinue use immediately. If you have a prescription, consult your doctor before you stop taking this or any other medication. They may want to prescribe an alternative without any lapse.

Currently Reviewing Zantac Claims

The experienced and skilled Austin defective drug attorneys at Shaw Cowart, LLC, are currently reviewing claims related to Zantac. If you have developed an illness, injury or have been diagnosed with cancer, and you have a history of Zantac use, please contact us for a free consultation at 512-499-8900.