Conflicting views on how to take aspirin and ibuprofen
Millions of people at risk for heart attack or stroke take a small daily dose of aspirinit has been shown to reduce the incidence of these events by about 25 percent. Now the Food and Drug Administration wants them to watch the clock before swallowing an ibuprofen product, such as Advil or Motrin, to relieve pain. An FDA safety alert issued last week advises consumers to wait at least 30 minutes to take ibuprofen after taking aspirin, and not to take aspirin for heart benefits for at least eight hours after taking ibuprofen. If the two drugs are used too closely together, warns the FDA, the ibuprofen may cancel out the aspirin's benefits.
But the FDA's action seems unwarranted to some experts. They worry that it may discourage doctors from putting patients in pain on a cheap and effective drug. And it conflicts with several studies, the latest of which was published online this week in the Journal of the American Medical Association, which found no interaction between the two medications.
The reason for the alert, according to an FDA spokesman, was unpublished data submitted by an unnamed pharmaceutical companydetermined by U.S. News to be Wyeth Consumer Healthcare, maker of Advilthat demonstrated an interaction between the drugs. The agency then reviewed published studies, some of which also showed an interaction. Aspirin reduces heart risk by interfering with the process that causes platelets to clump together and form blood clots. Ibuprofen seems to temporarily get in the aspirin's way. If the two drugs are taken closely together, some researchers say, part of the aspirin will be gone from the bloodstream by the time the effect of the ibuprofen ebbs. That leaves less protection behind.
But other investigators have found little or no interaction between ibuprofen and aspirin. Besides the JAMA study, for example, a 2003 study in the British Medical Journal of nearly 70,000 heart-attack patients age 65 and older concluded that the two drugs "did not adversely interact."
"I think [the safety alert] is much ado over no data," says Steven Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine and an expert on the heart risks of pain-relief drugs. "I don't know why the FDA did thisthe whole damn thing just doesn't make any sense. It will confuse clinicians and it will confuse the public."
Nissen and others worry that patients who need heart protection but are also desperate for pain relief from arthritis and other chronic conditions may be steered away from ibuprofen. Like other nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen is already under a cloudthe FDA now requires NSAID labels to carry a warning that long-term regular use "may increase the risk of heart attack or stroke." If physicians nudge patients away from ibuprofen, that would further reduce an arsenal of pain drugs already diminished by concerns about the heart risks of Cox-2 inhibitors.
For those who take ibuprofen occasionally, the lack of conclusive evidence that it interferes with aspirin's heart-protective benefits is immaterial. It's a simple matter to space out the ibuprofen doses. Those who use it regularly at full strength for up to 10 daysthe maximum approved dosage without a physician's advicemight even follow Wyeth's own recommendations, more conservative than the FDA's, based on blood tests of 47 volunteers. Ibuprofen should be taken a full hour after aspirin, and at least 11 hours should separate the last ibuprofen of the day from the next day's first aspirin, says Suman Wason, senior director, global medical affairs, of Wyeth Consumer Healthcare. "This is a very complicated situation," says Wason. "We have defined a regimen that we think can be followed with absolute safety."