Safety alert
Which pain reliever should you take?
On April 7, the Food and Drug Administration announced that most prescription pain relievers--not just the Vioxx family of COX-2 inhibitors that has long provoked the greatest concern--must carry "black box" warnings about increased risks of heart attack, stroke, and gastrointestinal bleeding. At the same time, Pfizer pulled its COX-2 inhibitor Bextra off the market after the FDA warned not only about the drug's cardiovascular risks--the reason for Merck's withdrawal of Vioxx in September 2004--but also about rare, potentially deadly skin reactions, which the agency said are much more likely with Bextra than with other pain relievers.
In light of those actions, millions of Americans must now make some difficult decisions. What should people who were taking Bextra or Vioxx--or the remaining COX-2 drug, Celebrex--do now? Are over-the-counter versions of the other suspect pain relievers riskier than previously thought? Indeed, are any pain relievers safer than others and, if so, is it worth making the switch? Or should people consider other options entirely?
The suspect medications are all nonsteroidal anti-inflammatory drugs (NSAIDs), a large group that includes common over-the-counter medicines such as ibuprofen (Advil, Motrin IB) and naproxen (Aleve) as well as many prescription medications, such as the COX-2 inhibitors and stronger versions of the OTC drugs. At equivalent doses, NSAIDs relieve pain equally well in general, although some individuals apparently experience greater relief from one drug than another. And all are reasonably safe when used properly for short-term pain relief, from a headache or muscle strain, for example. That's why the FDA did not require the black-box warning on the OTC pain relievers, which should be used only in that limited way, although the agency did mandate stronger warnings about inappropriate use.
But when taken for more than a few weeks to treat osteoarthritis or other chronic pain, especially at high doses, all NSAIDs can raise blood pressure, irritate the lining of the stomach and intestines, and possibly stimulate blood clotting. So they all can potentially increase the risks of serious cardiovascular and gastrointestinal problems. And even brief use of any NSAID can in rare instances trigger severe skin reactions--possibly including Stevens-Johnson Syndrome, which causes blistering, especially in and around the mouth, and can lead to fatal organ failure.
However, despite the FDA's blanket warning, our medical consultants say there are probably differences in the risks posed by various NSAIDs. For example, Celebrex appears to increase cardiovascular risk more than older NSAIDs--particularly naproxen and probably ibuprofen, too--though it may be somewhat safer for the heart and brain than Vioxx and Bextra. And Celebrex may be a bit less likely to cause internal bleeding than the older NSAIDs. That's usually a lesser concern than the cardiovascular risks, except for people with increased susceptibility to gastrointestinal problems.
People who have chronic pain--including those treating it with OTC drugs--should be under a physician's supervision. Your doctor should regularly reassess your health status, particularly your risk of heart attack, stroke, and gastrointestinal bleeding, and consider nondrug measures for easing pain.
If you need drugs, the optimal choice depends on your individual health risks, which pain reliever seems to work best for you, and how concerned you are about the cost. But in general, we recommend the following:
Whichever NSAID you use, take these protective steps:
In light of those actions, millions of Americans must now make some difficult decisions. What should people who were taking Bextra or Vioxx--or the remaining COX-2 drug, Celebrex--do now? Are over-the-counter versions of the other suspect pain relievers riskier than previously thought? Indeed, are any pain relievers safer than others and, if so, is it worth making the switch? Or should people consider other options entirely?
THE RISKS
The suspect medications are all nonsteroidal anti-inflammatory drugs (NSAIDs), a large group that includes common over-the-counter medicines such as ibuprofen (Advil, Motrin IB) and naproxen (Aleve) as well as many prescription medications, such as the COX-2 inhibitors and stronger versions of the OTC drugs. At equivalent doses, NSAIDs relieve pain equally well in general, although some individuals apparently experience greater relief from one drug than another. And all are reasonably safe when used properly for short-term pain relief, from a headache or muscle strain, for example. That's why the FDA did not require the black-box warning on the OTC pain relievers, which should be used only in that limited way, although the agency did mandate stronger warnings about inappropriate use.
But when taken for more than a few weeks to treat osteoarthritis or other chronic pain, especially at high doses, all NSAIDs can raise blood pressure, irritate the lining of the stomach and intestines, and possibly stimulate blood clotting. So they all can potentially increase the risks of serious cardiovascular and gastrointestinal problems. And even brief use of any NSAID can in rare instances trigger severe skin reactions--possibly including Stevens-Johnson Syndrome, which causes blistering, especially in and around the mouth, and can lead to fatal organ failure.
However, despite the FDA's blanket warning, our medical consultants say there are probably differences in the risks posed by various NSAIDs. For example, Celebrex appears to increase cardiovascular risk more than older NSAIDs--particularly naproxen and probably ibuprofen, too--though it may be somewhat safer for the heart and brain than Vioxx and Bextra. And Celebrex may be a bit less likely to cause internal bleeding than the older NSAIDs. That's usually a lesser concern than the cardiovascular risks, except for people with increased susceptibility to gastrointestinal problems.
OUR RECOMMENDATIONS
People who have chronic pain--including those treating it with OTC drugs--should be under a physician's supervision. Your doctor should regularly reassess your health status, particularly your risk of heart attack, stroke, and gastrointestinal bleeding, and consider nondrug measures for easing pain.
If you need drugs, the optimal choice depends on your individual health risks, which pain reliever seems to work best for you, and how concerned you are about the cost. But in general, we recommend the following:
- First choice for everyone: the non-NSAID acetaminophen (Panadol, Tylenol). It's reasonably safe even for frequent or prolonged use, provided you don't exceed the recommended doses, and the generic version is very cheap. Avoid acetaminophen if you drink alcohol heavily or have a liver disorder.
- If acetaminophen doesn't do the job: Try naproxen or ibuprofen, or consider salsalate, a prescription relative of aspirin. Those drugs are probably safer for the heart than Celebrex and possibly three other prescription drugs--diclofenac (Cataflam, Voltaren), indomethacin (Indocin), and meloxicam (Mobic). And over-the-counter generic versions of ibuprofen and naproxen are cheaper than other NSAIDs except aspirin, which is harder on the stomach. The OTC generics are particularly good choices for people who need low or modest doses. Individuals who require higher doses and want the convenience of taking fewer pills should consider either salsalate or prescription, generic ibuprofen, both of which cost significantly less than other prescription NSAIDs and are equally effective.
- If you're taking low-dose aspirin to protect your heart: Let at least two hours elapse after your aspirin dose before taking any NSAID, since such drugs may interfere with aspirin's cardiac benefits.
- If you've had gastrointestinal ulcers or bleeding, or GI reactions to any NSAID: Avoid all NSAIDs if the problem is recent, generally within a year or so. If it happened less recently, talk with your doctor about adding a stomach-protecting drug such as omeprazole (Prilosec, Prilosec OTC, generic) or possibly misoprostol (Cytotec).
- If all else fails, and your doctor determines that you have no increased coronary risk: Consider Celebrex, but strictly as a last resort.
FINAL PRECAUTIONS
Whichever NSAID you use, take these protective steps:
- Monitor your blood pressure regularly and make the lifestyle changes that can help control blood pressure, such as consuming less sodium, losing excess weight, and exercising regularly.
- Contact your doctor immediately if you notice any unexplained blisters or rashes. There's no way to tell beforehand whether you're susceptible to such NSAID reactions.
- Use NSAIDs mainly to treat flare-ups, not to prevent pain.
- Stick to the lowest effective dose.
This site is for your information only. For medical advice, consult a health professional.
© Consumers Union 2005
