Drugs

ECAN OTC Heartburn Drug Petition Denied

FDA has denied a 5/1/17 petition submitted on behalf of Esophageal Cancer Action Network and asking that the agency require a new warning concerning the risk of esophageal cancer for all over-the-counter (OTC) drug products labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion, and sour stomach. The petition also said that warnings for the products should note that the OTC products do not eliminate the risk of esophageal cancer, and that people should see their doctor if they experience persistent heartburn associated with reflux disease, acid indigestion, or sour stomach due to the risk of esophageal cancer.

In its response, FDA says it considered the petition and conducted its own review of the available literature and data on OTC products labeled to treat heartburn and their potential relationship with Barrett’s esophagus and esophageal cancer. “After careful consideration, we have found that the current required and FDA approved labeling for OTC products labeled to treat heartburn is adequate to alert consumers about appropriate use of these products,” it says.

The petition says that available studies and data do not show that OTC drugs labeled to treat heartburn are associated with delayed diagnoses of esophageal cancer. “The current warnings for all OTC heartburn products are appropriate,” FDA concludes. “All OTC products labeled to treat heartburn are specifically labeled for short-term use, and patients are instructed to seek medical care if heartburn continues for longer than the specified short-term period or warned that use beyond the specified short-term period should only be pursuant to the advice and supervision of a physician.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome