Last month an expert panel said the arthritis drug Vioxx (search) can return to the market and sister drugs Celebrex (search) and Bextra (search) should continue to be sold. And now the American Heart Association (search) has issued an advisory to help people understand how to more safely take painkillers.
Call for ‘Common Sense’
“We are recommending that patients use some common sense in selecting medication to treat pain,” says Joel Bennett, MD, who worked on the AHA’s advisory. Bennett commented in an AHA news release.
“In terms of drug choice, one rule is always best and it holds whether you are treating cancer or treating a headache: Use the safest medicine first,” says Bennett, a University of Pennsylvania professor of medicine.
That could mean starting with over-the-counter pain relievers aspirin and acetaminophen (search), says the news release. “If those medicines don’t work, try a stronger nonsteroidal anti-inflammatory drug (NSAID) such as Aleve (naproxen),” says Bennett.
Patients should see a doctor if they need an over-the-counter painkiller for more than 10 days, the AHA advisory says.
The advisory comes in the wake of concerns about painkiller safety — particularly for arthritis drugs called Cox-2 inhibitors. Vioxx, Bextra, and Celebrex are Cox-2 inhibitors (search).
The FDA is expected to rule within the next few weeks on Cox-2 safety. Late last year, the FDA issued a public health advisory about painkillers. The AHA’s advisory echoes those FDA recommendations.
Concerns Over Safety
Cox-2 drugs hit the headlines last year over reports of higher risk of heart problems and stroke in some patients.
The drugs are valued for their effects on arthritis pain. They were developed to be “good pain relievers that wouldn’t upset the stomach, which sounded great,” says Bennett, in the news release.
Bennett and colleagues don’t dismiss Cox-2 drugs. However, the AHA advisory suggests that those drugs may not be appropriate for all patients. That’s something that doctors and patients must consider on a case-by-case basis, looking at the patient’s heart health and other medical needs.
Cox-2 drugs should be “held in reserve, generally for short-term use,” says Bennett.
The AHA and FDA’s recommendations say Cox-2 inhibitors should be limited to:
—Patients who are at high risk of stomach or intestinal bleeding. This includes people with a prior ulcer or taking blood thinners, such as Coumadin.
—Patients who have a history of being unable to tolerate traditional anti-inflammatory drugs.
—Patients who are not doing well on traditional anti-inflammatory drugs.
If needed, Cox-2 inhibitors should be used at the lowest dose for the shortest time possible.
Here’s a quick review of the controversy:
Vioxx. Last September, drug maker Merck (search) voluntarily took Vioxx off the market worldwide because of an increased risk of heart attack and stroke. That prompted calls for a broader look at other Cox-2 inhibitors. After extensive review an expert FDA panel recommended last month to allow Vioxx back on the market. This would need official FDA approval and cooperation of the manufacturer. The FDA is expected to rule within the next few weeks.
Celebrex. Data have been mixed. Last December, the National Institutes of Health (search) abruptly stopped a clinical trial using Celebrex after finding that patients taking Celebrex had 2.5 times the risk of heart attack or strokeas patients taking a placebo. However, the Celebrex group was taking 400 milligrams per day — twice the normal amount.
Another NIH study using Celebrex was also halted. This time, the problem wasn’t Celebrex. The study’s 8,000 participants taking Celebrex did not have a higher risk of heart problems. Instead, other participants taking the pain-relief drug Aleve (naproxen) had an increased risk of heart trouble. But the FDA panel said that the alert about Aleve was unjustified and there was little or no risk from Aleve.
Bextra. Last December, the FDA warned that Bextra should not be used in patients having heart bypass surgery.
The final word on painkiller safety isn’t in yet.
“It should be recognized that with the exception of aspirin, the ‘low-risk’ medications mentioned have not been subjected to randomized clinical trials to conclusively demonstrate their safety,” says the AHA advisory. Low-risk medications refer to traditional anti-inflammatory drugs, including ibuprofen (search), indomethacin (search), and naproxen (search).
Patients should ask their doctors about their recommendations, including whether low doses of aspirin might help cut their heart attack risk.
The AHA’s advisory appears in the April 5 issue of Circulation.
SOURCES: Bennett, J. Circulation, April 5, 2005. News release, American Heart Association. WebMD Medical News: “Celebrex, Bextra Face FDA Scrutiny This Week.”