Wednesday, June 25, 2003

Heartburn pill to be sold over-the-counter

By Peggy O'Farrell
The Cincinnati Enquirer

The purple heartburn pill will turn salmon pink and be available over-the-counter later this year, thanks to a decision Friday by the Food and Drug Administration to make Prilosec available without a prescription.

Prilosec, a proton-pump inhibitor, is recommended for treating frequent heartburn that occurs two to three days a week. Currently available over-the-counter remedies are recommended for heartburn caused by spicy meals or overindulging at the dinner table. Procter & Gamble, the makers of Prilosec, say the over-the-counter version could be available in early fall. The price hasn't been set, but it should cost less than $1 a pill.

Dr. Dan Fagel, a gastroenterologist with Tristate Gastroenterology Associates in Edgewood, talks about the FDA's decision and when it's time to see a doctor.

Question: What's it mean to consumers to have Prilosec available without a prescription?

Answer: Clearly, it will be the most effective over-the-counter agent available to them. We've been using it since 1989 and it's made our job a lot easier.

Q: Does Prilosec work for most reflux patients?

A: Most patients respond very well to that class of medicine, which is a proton-pump inhibitor. It actually shuts down the pumps that produce acid in the stomach.

Q: How common is heartburn?

A: It affects 44 percent of the population, and 7 percent of the population have it on a daily basis.

Q: Is medication the only option for heartburn sufferers?

A: I think of heartburn the way most people think of hypertension: Once you've got it, you're probably always going to have it. Lifestyle changes can make a difference, but they're hard to make. Even for people who have to see me, approximately 25 percent will have significant relief with just lifestyle changes, like controlling your weight, what and when you eat, smoking, alcohol, caffeine, eating late at night. All of those habits contribute.

Q: How do consumers know when it's time to stop relying on over-the-counter medications and when to see a doctor?

A: There are different aspects that we treat. For gastroenterologists, we're concerned about relieving inflammation and relieving symptoms. The patients are concerned about relieving the symptoms. We're satisfied when we heal the inflammation and the patient feels better. And it's important to heal the inflammation because it can be associated with side effects, such as scar tissue and even precancerous conditions (Barrett's esophagus).

Q: What criteria should patients keep in mind when they decide whether or not to see a doctor?

A: The problem is if somebody treats themselves and keeps their symptoms under control, you may never know there are problems lurking, such as Barrett's. We use certain criteria. If it's a normal, healthy person in their 20s, we just treat them with lifestyle changes and acid relief. But if somebody has had it for 10 or 15 years or it starts after they're 50 or it doesn't respond to treatment or there are complications (chest pain, trouble swallowing), then they need to see a specialist.


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