How Safe Are Pain Medications?

Millions of people take pain medications. Drugs that contain ibuprofen, like Motrin® and Advil®, are the most commonly prescribed in the world. However, the recalls of Vioxx® and Bextra® (COX-2 inhibitors) and concerns over non-prescription drugs like Aleve® have raised new questions about the safety of all nonsteroidal anti-inflammatory drugs (NSAIDS).

What are NSAIDS and COX-2 inhibitors?

NSAIDS reduce redness, swelling and pain at the site of a muscle strain or arthritic joint. Examples of NSAIDS include Aleve, Motrin, Advil, Vioxx, Bextra and Celebrex®.

Vioxx, Bextra and Celebrex are COX-2 inhibitors, which are types of NSAIDS. These are a newer class of medications that are very effective for arthritis and less likely to cause stomach ulcers than older NSAIDS. They may also help prevent conditions like colon cancer and Alzheimer's disease.

What are the concerns over NSAIDS?

• Vioxx. A study was done to see if Vioxx could limit the return of colon polyps. The study was stopped after 18 months because some people taking the drug developed heart attacks and strokes. In September 2004, the manufacturer withdrew Vioxx from the market. Pharmacies can no longer fill prescriptions for it.
• Aleve. In December 2004, the National Institutes of Health stopped a clinical trial meant to show that Aleve (naproxen) reduced the risk of Alzheimer's disease. Researchers became concerned when the Aleve group experienced 50 percent more heart attacks and strokes than the placebo group. The public was warned by the FDA not to take more than the recommended dose of Aleve.
• Bextra. The FDA asked the manufacturer of Bextra to take it off the market in April 2005. The action came after two clinical trials. These trials were meant to show that Bextra was an effective pain reliever for use after heart surgery. They were stopped because an increase in heart attack and stroke was found in this group. Also, Bextra was already known to sometimes cause severe skin reactions, especially in children.
• Celebrex. Studies showed that this COX-2 inhibitor could cause cardiovascular risks. The purpose of the studies was to show that Celebrex could reduce the return of colon polyps. It is still available, but with strong warnings.

What is being done now?

The FDA has said that patient handouts must include more information about the risks. Other directions include:

• Not taking any NSAID just before or after heart surgery
• Watching for signs of stroke (weakness on one side of the body) or stomach bleeding
• Looking for signs of allergic reaction, including skin rash
• Not giving NSAIDS to children younger than 12 without first talking to your doctor
• Not taking the medication for more than 10 days

What drugs include new warnings?

Ask your doctor or pharmacist for a complete list of NSAIDS.

What should you do if you are taking pain medications?

First of all, don't panic if you are taking an NSAID. Remember that the majority of people who take these very common medications don't have heart attacks or strokes. If you are taking aspirin for pain or to reduce your risk of a heart attack, make sure you are on the right dose. Aspirin doesn't increase your risk for heart disease, but can lead to intestinal bleeding. Read any warnings and follow the label instructions carefully.

Questions for your doctor

• Do I have any conditions that may get worse if I take NSAIDs (such as asthma, kidney disease, ulcer)? Do I really need to be on an NSAID or is there a more effective pain reliever? Can NSAIDs interact with any other drug that I'm taking?
• Am I on the lowest effective dose for the shortest time?
• Am I fully protected against stomach ulcers? (Your doctor may add medication to increase your protection.)

Sources:

New England Journal of Medicine

The National Arthritis Foundation

U.S. Food and Drug Administration

Food and Drug Administration

Stevens Johnson Syndrome Foundation