Zantac Contamination Prompts Recall from Markets Worldwide

Zantac, a popular over-the-counter medication used to treat heartburn, was recalled from store shelves in multiple countries due to contamination reports. The United States Food and Drug Administration (FDA) discovered potentially dangerous levels of N-nitrosodimethylamine (NDMA) in the medicines — the same carcinogenic chemical that caused multiple blood pressure medications to be recalled starting in 2018.

Ranitidine is the generic name for Zantac. It can be found in a pill form, as well as in syrups and injectable methods of heartburn treatment. Zantac is produced by the pharmaceutical company GlaxoSmithKline (GSK). The FDA has not expanded the recall to include all forms of ranitidine; the order is currently limited to the Zantac brand.

What are the Effects of NDMA Exposure?

The true effects of NDMA contamination in Zantac and the recalled blood pressure medications are still under investigation. The impurity has been identified as a carcinogen and is specifically “linked to an increased risk for colorectal and uterine cancers,” according to a report from NBC News. The FDA is examining how much NDMA was present in the contaminated medications, and if the present amount is hazardous. An article from CBS News explained that the drug’s interactions inside the body could cause ranitidine to convert to high levels of NDMA.

What Caused the Contamination?

Zantac and many other medications are produced in other countries. International pharmaceutical manufacturing plants are often not subject to strict regulations. The NDMA contamination, according to initial reports, appears to be linked to the drug manufacturing process. However, an exact cause has not been identified.

What if I Use Zantac?

If you rely on Zantac as a heartburn solution, consult with your doctor to determine if an alternative treatment plan is necessary. The FDA is not currently advising patients to stop taking Zantac, and explained that the agency “does not have scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines at this time.” Although there are no certain orders to halt the use of ranitidine drugs, the FDA did highlight the availability of a variety of other over-the-counter heartburn medications.

Brett H. Oppenheimer, PLLC represents the rights of people who were injured by the use of dangerous drugs and medical devices. If you have a claim related to Zantac or another medication, contact us to schedule a free case evaluation.

To get in touch with our attorney, complete our contact form or call (502) 242-8877.

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