FDA Approves Prilosec OTC to Treat Frequent Heartburn

June 20, 2003 -- The Food and Drug Administration (FDA) today announced the approval of Prilosec OTC (omeprazole), the first over-the-counter treatment for frequent heartburn.

"Today's approval of over-the-counter Prilosec is yet another example of the important role FDA serves in improving access to safe and effective treatments for conditions that people can treat themselves," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "As has been the case for many other over-the-counter switches, the availability of Prilosec OTC will help reduce costs and expand the availability of treatment options for millions of Americans."

Unlike the two classes of currently marketed over-the-counter heartburn treatments, antacids and acid reducers, Prilosec OTC is indicated for the treatment of heartburn that occurs two or more days per week (frequent heartburn). It stops acid production at its source in the stomach. Prescription Prilosec is currently widely prescribed for frequent heartburn and other related, but more serious, problems that need the care of a physician. Antacids and acid reducers, which have long been available over-the-counter, are used for the relief of acute heartburn symptoms. Acid reducers are additionally used for the prevention of meal-induced heartburn.

According to the American College of Gastroenterology, over 60 million Americans experience heartburn at least once a month and some studies have suggested 15 million Americans experience heartburn daily. Heartburn occurs when stomach contents containing acid back up and out of the stomach into the esophagus causing a burning sensation in the chest or throat.