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David Baxter PhD

Late Founder
Over-the-Counter Drugs Can Pack a Punch
Fri Sep 3, 2004
By Holly VanScoy, HealthDay

FRIDAY, Sept. 3 (HealthDayNews) -- The ever-increasing number of medicines available without a prescription has been a godsend for many Americans.

Consumers can now gain access to treatments for ills ranging from fever, pain, itching and gastrointestinal upset -- to name just a few -- without having to consult a health professional.

And over-the-counter drugs typically cost much less than prescription medications.

But experts warn that over-the-counter doesn't mean risk-free. Many consumers often don't know how to make the best drug selection, potentially risking serious illness or even death with their choice and dosing decisions.

Americans spend an estimated $5 billion dollars on OTC products every year.

According to the U.S. Food and Drug Administration, there are presently more than 80 therapeutic categories for non-prescription drugs, ranging from acne medications to weight control products.

As with prescription medicines, the FDA oversees over-the-counter drugs to ensure they are properly labeled and that their benefits outweigh their risks. The agency's Center for Drug Evaluation and Research defines OTCs in terms of five characteristics:
  • their benefits outweigh their risks;
  • the potential for misuse or abuse is low;
  • consumers can use them for self-diagnosed conditions;
  • they can be adequately labeled;
  • a health practitioner's advice is not needed for their safe and effective use. [/list:u]Emily Evans is a clinical pharmacist and assistant professor of pharmaceutical practice at the South University School of Pharmacy, in Savannah, Ga. She said these guidelines don't mean consumers should be less cautious when using over-the-counter drugs, compared to medications that require a prescription.

    "OTCs are often powerful medications," Evans said. "Some of them were available only by prescription just a short time ago. Consumers make a mistake if they think they aren't potentially dangerous, just because the decision of which one to buy and what strength to take is entirely in their hands."

    Evans noted that some consumers are at higher risk of having a bad experience with over-the-counter drugs. They include senior citizens, people taking several prescription or multiple OTC drugs, and those who have chronic medical conditions, such as high blood pressure, asthma or diabetes.

    "Even the safest drugs can cause serious problems, she said, "including popular OTCs such as diphenhydramine, sold under the trade name Benadryl, and ibuprofen, sold under a number of trade names, including Motrin."

    Pat Carroll, a registered nurse from Meriden, Conn., and author of What Nurses Know and Doctors Don't Have Time to Tell You, shares Evans' concerns. She said one of the biggest problems is that many OTCs are multi-purpose medications that can contain several powerful ingredients.

    "Consumers should choose single-ingredient OTC remedies whenever they can," she said. "That way, they know exactly what they are taking, and there are no hidden ingredients to cause trouble."

    As an example, Carroll pointed to unintentional acetaminophen overdoses that occur because many people don't realize the popular pain reliever is in their "maximum strength sinus, cold and allergy medicines."

    "In addition to their multi-purpose OTC, some individuals take two acetaminophen tablets, such as Tylenol, for their splitting headache," she said. "The toxic range for acetaminophen starts at 5 grams a day, and the maximum recommended dose is 4 grams a day -- a slim margin of just two extra-strength tablets."

    The U.S. Food and Drug Administration reports that 458 people a year in the United States die of complications related to acetaminophen. About 100 of those deaths are thought to be unintentional, according to a 2002 report on acetaminophen toxicity.

    In addition, acetaminophen poisoning sends more than 56,600 people to the emergency room each year and leads to 26,000 hospital admissions. Children make up 22 percent of unintentional hospital cases, according to the FDA.

    Another area of concern, Carroll and Evans agree, is the possible interaction between prescription drugs and over-the-counter drugs. The same holds true for potential interactions between OTCs and herbal remedies, and herbal remedies and prescription drugs.

    "Most folks don't consider herbal remedies to be drugs, even though herbals affect the body as drugs do," Carroll said. "For example, black cohosh, often used for menopause symptoms, can lower blood pressure and exaggerate the effect of high blood pressure medications. Garlic remedies can enhance the effects of anticoagulant drugs, and St. John's wort can reduce the effects of these medications, as well as the effectiveness of many birth control pills."

    Evans recommends that consumers discuss every drug they're taking -- whether an OTC, herbal or prescription medication -- with their primary-care physician, or with emergency room staff when urgent care is needed.

    "Lives have been lost because physicians were not aware of the OTC medications a patient had taken," she said.

    Evans also recommends that consumers do their homework, either online or using one of the many consumer-friendly books available, before visiting the OTC aisle.

    And don't forget to consult with a pharmacist, she reminds consumers who may find themselves trying to decide between a bewildering array of OTCs for even the simplest ailment.

    "Take your OTC to the pharmacy and ask for advice or recommendations," she said. "That's what pharmacists are trained to provide, even for OTCs."

    More information
    The Center for Drug Evaluation and Research offers valuable information about over-the-counter drugs.
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