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Panel Backs Over-the-Counter Prilosec
Heartburn Medication May Soon Be Sold Without Prescription


June 27, 2002 -- The first drug of its class may soon join the ranks of other over-the-counter heartburn medications lining drug store shelves. An FDA advisory panel has now recommended that the popular drug Prilosec be made available without a doctor's prescription.

If approved for nonprescription use, Prilosec is expected to have a major impact on the billion-dollar over-the-counter heartburn medicine market currently dominated by antacids such as Tums and Rolaids and acid reducers such as Pepcid, Tagamet, and Zantac.

The panel recommended that Prilosec be approved only for treating heartburn that occurs two or more days a week and not for treating occasional stomach problems that are often caused by eating too much pizza or spicy food.

The FDA is not required to follow the panel's recommendation, but it usually does. An official ruling from the agency is expected by the end of summer.

Produced by drugmaker AstraZeneca, Prilosec is one of the most popular and profitable prescription drugs in the world, racking up $6 billion in sales in the year 2000. AstraZeneca has sold the rights to a nonprescription version of the drug, to be sold under the name Prilosec 1, to Procter & Gamble.

If approved for over-the-counter use, the cost of the drug is also expected to drop from about $4 a day to $1 a day in the nonprescription form.

Greg Allgood, PhD, associate director of the Procter & Gamble Health Sciences Institute, says about 40 million Americans experience heartburn at least twice a week and would benefit from the new over-the-counter version of Prilosec.

"They're going to be better off because the drug is more effective than what they're using now," Allgood tells WebMD. Allgood says Prilosec 1 would be the only over-the-counter heartburn medication on the market that has been proven to prevent chronic heartburn before it starts.

Antacids such as Tums and Rolaids work to neutralize heartburn-related acids after symptoms begin to provide relief. And histamine blockers such as Pepcid, Zantac, and Tagamet are designed to manage sudden episodes of heartburn when taken at certain times, such as before or after spicy meals.

Prilosec 1 would be the first in its class to be sold without a doctor's prescription. It works by shutting down the pump that produces the stomach acids that lead to the burning sensations in the chest and neck associated with heartburn.

Allgood says studies have shown that taking Prilosec once a day for 14 days can prevent heartburn from happening in most people and keep it from coming back for up to 8 weeks at a time for up to 43% of patients.

According to the drug labeling recommended by the FDA panel, people whose heartburn does not improve after 14 days of treatment with Prilosec should see their doctor for evaluation.

Some members of the panel had expressed concern that people taking an over-the-counter version of Prilosec may be at risk for masking a more serious condition that would require a doctor's attention. In 2000, the FDA panel refused a broader application for over-the-counter status for Prilosec because it feared consumers may not use the drug appropriately.

But David Peura, MD, professor of medicine and associate chief of gastroenterology and hepatology at the University of Virginia, says people with other conditions commonly associated with heartburn -- such as gastoesophageal reflux disease (GERD) or ulcers -- would probably not find relief from Prilosec and should see a doctor if their symptoms persist.

Peura, who is also a spokesman for the American Gastroentological Association, says he's in favor of Prilosec becoming available over the counter because it will give greater access to the millions who suffer from heartburn to a more effective therapy.

"We know from 15 years of experience that [drugs] like Prilosec work better than anything else that's available," says Peura. "You'd have to take cases of antacids to get the same effect as Prilosec, and it will save consumers money, too."

Even so, he says medications aren't the only way to get your heartburn under control.

"Medicine is important, but it is not the end all," Peura tells WebMD. "There are still many important things that people can do to help themselves -- what they eat, when they eat, how much they eat, correcting some of the bad habits they have are also very important."