New drugs mean self-education for consumers HEAL THYSELF

September 05, 1995|By Patricia Meisol | Patricia Meisol,Sun Staff Writer

In the next year, you will be bombarded with $300 million worth of messages about new, over-the-counter drugs to relieve indigestion.

Your stomach cringes after pizza? Mexican food? Coffee? Suffer no longer, say the ads for Tagamet HB and Pepcid AC. The implication: Give up Tums and Rolaids and Mylanta for stronger stuff. Stuff sold under a name once available only by prescription.

Tagamet HB by SmithKline Beecham PLC, and Pepcid AC by Johnson & Johnson-Merck Co. Inc., are lesser-strength versions of popular drugs prescribed by doctors for ulcers (Tagamet and Pepcid). They are part of a whole new generation of stomach soothers that is expected to displace quickly antacids on the market.

And they are something more. Tagamet HB, which went on sale two weeks ago, and Pepcid AC, introduced two months ago, are the latest and biggest prescription drugs to be made available over the counter. But they won't be the last Rx-to-OTC switch.

The Food and Drug Administration is considering several dozen other drugs -- everything from pain relievers and cholesterol-lowering drugs to anti-viral agents and nicotine patches -- for over-the-counter use. The agency is expected to approve two more over-the-counter heartburn remedies later this year -- Zantac, made by Britain's Glaxo Wellcome PLC and now '' the biggest-selling ulcer prescription, and Eli Lilly & Co.'s Axid.

Since 1975, the FDA has approved 55 prescription drugs for over-the-counter sale, including Tylenol, Advil and ALEVE, an analgesic introduced in 1994 that was formerly prescribed by doctors for arthritis and inflammation.

For drug companies, over-the-counter sales can breathe new life into drugs that are in danger of losing their market to generics or new kinds of treatment. For consumers, over-the-counter drugs can save time and, in some cases, money.

Over-the-counter drugs generally are cheaper for the growing millions of people who don't have health insurance coverage. People with insurance, however, could find themselves paying $20 for a remedy that used to cost them just $5 by prescription. Their insurance companies are the major winners here.

"In some cases, it may cost more. But in purely dollars and cents, to get a prescription, you have to go see a doctor, and for millions of people, that is salary out the window," says Frank Rathbun, spokesman for the Washington-based Nonprescription Drug Manufacturers Association.

Increased access

Many consumer health groups and doctors welcome the trend because it increases access to health care and allows patients to self-medicate. But they warn it could prove costly to patients who try to cure themselves of illnesses that are far more serious than heartburn, or patients who over-medicate or mix medications.

"I'm all for trying something other than running to the doctor every few minutes," says Dr. I. A. Razzak, who treats digestive diseases as chief of gastroenterology at the Greater Baltimore Medical Center.

"On the other hand, I am very concerned about people taking the medication when they should be diagnosed first." The new medications are fairly safe and very effective, he says, but "I still think it's not a bad idea to call the family doctor."

The promotion of over-the-counter drugs is likely to result in increased drug use for ailments that can or should be controlled in other ways -- in the case of gastrointestinal diseases, by watching your diet, by surgery and by newer prescription drugs.

One complaint is that manufacturers aren't educating consumers enough when the switch occurs.

"People just assume the OTC is safe. It's safe if you follow directions and if you heed the warnings," says Linda Golodner, ++ president of the National Consumers League, which is lobbying for better labeling and more manufacturer education.

Another concern is reactions from certain foods or other over-the-counter drugs. "People will tend to mix and match their medications until their headaches and heartburn go away," says Ms. Golodner. "We do encourage people to ask a pharmacist, but OTC drugs are not just OTC drugs in a drugstore -- they are OTC in a gas station."

When a drug becomes over-the-counter, it goes from being sold at 50,000 pharmacies to being available at 750,000 to 800,000 groceries, convenience stores, K marts and other retail outlets, says Francis Palumbo, professor and director of the Center on Drugs and Public Policy at the University of Maryland School of Pharmacy.

"You have to assume that someone was looking out for the patient when it was prescription, either the doctor or the pharmacist," he says. "But now, with 750,000 outlets where they can get it, there's obviously no one helping to counsel on the use of these products."

Over-the-counter switches are usually lower-dose versions of prescription drugs. They are not meant for long-term use.

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