Petition Seeks OTC PPI Warning On Cancer Risk From Persistent Heartburn

OTC proton pump inhibitors should carry a warning that the products do not eliminate risks of esophageal cancer from persistent heartburn, says the Esophageal Cancer Action Network in a citizen petition to US FDA. FDA should “immediately” require the warning, which should be bold and prominent.

FDA is being asked to add yet another safety warning to OTC proton pump inhibitors. A citizen petition requests requiring a label warning on the risk of esophageal cancer from persistent heartburn, a risk not lessened by PPI use.

“The warnings on current products are not sufficient to alert patients to the risk of esophageal cancer associated with persistent heartburn resulting from reflux disease, acid indigestion or sour stomach,” states Esophageal Cancer Action Network Inc. in a

ECAN President Mindy Mintz Mordecai and Chairman John Lipham explain in the petition that because PPIs are effective in providing symptomatic relief, many patients likely do not seek medical intervention for the persistent heartburn that can lead to Barrett’s esophagus – a precancerous

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