Could the active ingredient ranitidine in brand-name and generic versions of the heartburn medication Zantac cause carcinogens to form in the bellies of users? That possibility, first raised by Valisure, an online pharmacy that originally raised red flags about the potential contamination to the Food and Drug Administration (FDA), is now being investigated by the FDA.
Ranitidine is sold over-the-counter and by prescription under various names. Several drug makers have recalled the products after the FDA announced concerns about possible contamination with N-nitrosodimethylamine, or NDMA, a probable carcinogen. The same impurity was found last year in a type of high blood pressure and heart failure drugs known as angiotensin II receptor blockers, or ARBs, leading to numerous recalls. It is believed that contamination is due to recent changes in the manufacturing process of those drugs.
But NDMA in ranitidine appears to be a different issue entirely. The FDA is “working to understand what happens to NDMA levels in the body, after raitidine has been exposed to acid in the stomach,” said FDA spokesman Jeremy Kahn.
Valisure’s Chief Executive David Light says that’s an important step because from his company has found the NDMA levels that can form in the body “are many magnitudes of order higher than what’s been talked about in the contamination,” he said. “This is one of the main red flags we’ve raised the whole time – not just contamination but the fact that this is happening in the human body.”
Over concern, many retailers have pulled OTC heartburn meds that contain ranitidine from their shelves, including Walmart, CVS Health, Walgreens, and Rite Aid.
Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.