Confused about anti-inflammatory drugs? The latest update about arthritis drugs and painkillers has even surprised and bewildered arthritis specialists. Here's the down-and-dirty version of what you need to know.
Bextra
—Bextra was pulled from the market because the FDA says that risks from Bextra outweigh the benefits.
—The FDA says Bextra offers no advantages over other available anti-inflammatory drugs.
—Risks from Bextra include an increase in heart attacks and strokes as well as the potential for life-threatening skin reactions.
—Patients should contact their doctor about choosing another treatment.
Celebrex
—Unlike Bextra, the FDA says the benefits of Celebrex outweigh the risks.
—Celebrex is associated with an increase in heart attacks and strokes, particularly at doses higher than 200 milligrams a day.
—Celebrex will carry a black box warning about the risks of heart attack, stroke, and stomach ulcer bleeding.
—Patients should use the lowest effective dose for the shortest time possible.
—More research is being done to study any potential long-term effects of Celebrex.
Vioxx
—In February, an expert panel recommended that Vioxx be brought back on the market after it was removed in September 2004 because of its link to heart attacks and strokes.
—However, the FDA says much more safety information is needed before Vioxx would be allowed back on the market.
—Experts say once patients stopped taking Vioxx, any increase in heart attacks and strokes likely went away.
—On Friday, a Texas jury awarded a woman nearly a quarter-billion dollars in a lawsuit against Merck, the makers of Vioxx, over the death of her husband from a heart attack allegedly brought on by Vioxx.
Other Prescription Anti-Inflammatory Drugs
The FDA says all anti-inflammatory drugs carry a risk of heart attacks and strokes as well as the risk for potentially life-threatening stomach ulcer bleeding. These drugs should not be used in patients who have recently undergone heart bypass surgery. The FDA has provided a complete list of drugs affected by this update.
Over-the-Counter Anti-Inflammatory Drugs
—Short-term, low-dose use (the recommended over-the-counter dose) of over-the-counter painkillers does not appear to increase risk of heart attacks and strokes.
—More specific information about the potential for heart attack, stroke, and stomach ulcer bleeding will be included with these products.
—The exact risk of these drugs isn't known because there is very little research in this area.
—These drugs include products with ibuprofen, naproxen, or ketoprofen. The FDA has provided a list of brand names for these over-the-counter medications.
—Stronger reminders about limiting the dose and duration of treatment will be included. Previous recommendations have been to use these over-the-counter drugs for no more than 10 days without seeing your doctor.
—Like prescription anti-inflammatory drugs, over-the-counter drugs also carry the risk of skin reactions.
—Aspirin is not included in this new warning as it's known to decrease the risk of heart disease. —Acetaminophen (Tylenol) is also not included in this warning as it is not an anti-inflammatory drug. It should still be taken as directed because too much acetaminophen can lead to liver problems.
Who is at highest risk when taking these drugs?
—Patients who have had recent heart bypass surgery
—People with heart disease — blockages in their heart arteries — including people who have had chest pain or a heart attack
—People who have had a stroke or who currently have episodes known as TIA (transient ischemic attacks), sometimes called ministrokes
—People with a history of stomach ulcers
By Michael W. Smith, MD, reviewed by Charlotte E. Grayson, MD
SOURCE: FDA.
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