Safety alert
date: 9/12/2005
Pain-relieving drugs: New warnings about frequent use
Safety concerns about drugs like Vioxx, Bextra, and others have left many pain sufferers confused about their options.
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In yet another report about the possible risks of pain relievers, a Harvard study published in August 2005 indicated that women who regularly took acetaminophen (Panadol, Tylenol) had nearly a doubled risk of developing high blood pressure. However, this observational study was based merely on responses to questionnaires and has not been confirmed by other research, so it’s certainly not definitive. And another Harvard study, published the next month, found no such risk in men. Overall, it’s unclear whether acetaminophen actually has any negative effect on blood pressure.
Several months earlier, in April, drugmaker Pfizer pulled its pain reliever Bextra off the market after the Food and Drug Administration warned not only about the drug’s cardiovascular risks—the reason for Merck’s withdrawal of the closely related drug Vioxx in September 2004—but also about rare, potentially deadly skin reactions. The agency said those are much more likely with Bextra than with other pain relievers.
The FDA also required strong “black box” warnings about the cardiovascular risks—as well as the gastrointestinal risks—of the other closely related drug, celecoxib (Celebrex), and of many other pain relievers. The warning is now required on the prescription-strength versions of all nonsteroidal anti-inflammatory drugs (NSAIDs), a large group that includes common over-the-counter (OTC) medicines such as ibuprofen (Advil, Motrin IB) and naproxen (Aleve). In addition, the FDA mandated stronger warnings about inappropriate use of OTC NSAIDs.
In light of those developments, millions of Americans must make some difficult decisions. All NSAIDs as well as acetaminophen are still reasonably safe when used at recommended doses for short-term pain relief, from a headache or muscle strain, for example. However, even brief use of any NSAID can, in rare instances, trigger severe and potentially fatal skin reactions. Contact your doctor immediately if you notice any unexplained blisters or rashes, especially around the mouth.
But long-term use of pain relievers requires greater and more nuanced precautions, as the next section explains.
People taking painkillers, especially in high doses for more than just a few weeks, to treat osteoarthritis or other chronic pain should be regularly assessed by their physician for heart, stroke, and gastrointestinal risk, including any increases in blood pressure. They should also consider nondrug measures for easing pain, which might permit use of lower dosages.
If you need frequent pain medication, use it at the lowest effective dose to treat pain flare-ups, not to prevent pain. Optimal drug choice depends on your individual health risks and which pain reliever seems to work best for you, but in general we recommend the following:
Several months earlier, in April, drugmaker Pfizer pulled its pain reliever Bextra off the market after the Food and Drug Administration warned not only about the drug’s cardiovascular risks—the reason for Merck’s withdrawal of the closely related drug Vioxx in September 2004—but also about rare, potentially deadly skin reactions. The agency said those are much more likely with Bextra than with other pain relievers.
The FDA also required strong “black box” warnings about the cardiovascular risks—as well as the gastrointestinal risks—of the other closely related drug, celecoxib (Celebrex), and of many other pain relievers. The warning is now required on the prescription-strength versions of all nonsteroidal anti-inflammatory drugs (NSAIDs), a large group that includes common over-the-counter (OTC) medicines such as ibuprofen (Advil, Motrin IB) and naproxen (Aleve). In addition, the FDA mandated stronger warnings about inappropriate use of OTC NSAIDs.
In light of those developments, millions of Americans must make some difficult decisions. All NSAIDs as well as acetaminophen are still reasonably safe when used at recommended doses for short-term pain relief, from a headache or muscle strain, for example. However, even brief use of any NSAID can, in rare instances, trigger severe and potentially fatal skin reactions. Contact your doctor immediately if you notice any unexplained blisters or rashes, especially around the mouth.
But long-term use of pain relievers requires greater and more nuanced precautions, as the next section explains.
WHAT TO DO
People taking painkillers, especially in high doses for more than just a few weeks, to treat osteoarthritis or other chronic pain should be regularly assessed by their physician for heart, stroke, and gastrointestinal risk, including any increases in blood pressure. They should also consider nondrug measures for easing pain, which might permit use of lower dosages.
If you need frequent pain medication, use it at the lowest effective dose to treat pain flare-ups, not to prevent pain. Optimal drug choice depends on your individual health risks and which pain reliever seems to work best for you, but in general we recommend the following:
- First choice for everyone: Acetaminophen. As a pain medicine that isn’t an NSAID, this drug is reasonably safe even for frequent or prolonged use, provided you don’t exceed the recommended dose. Avoid acetaminophen if you have a liver disorder or drink alcohol heavily.
- If acetaminophen isn’t sufficient: Try NSAIDs, starting with ibuprofen, naproxen, or salsalate, a prescription relative of aspirin.
- If you’ve had gastrointestinal ulcers or bleeding caused by any NSAID: Avoid all NSAIDs if the problem occurred within the past year. If the problem was more remote, ask your doctor to provide a stomach-protecting drug along with the NSAID.
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