Vioxx, Celebrex, Bextra Recall News

Wednesday, March 23, 2005

Safe painkiller guide after Vioxx recall

Confused about which painkillers are safe to use? You are not alone. Recent controversy surrounding Cox-2 inhibitors like Vioxx, Celebrex, and Bextra and other over the counter drugs like Aleve has created so much confusion among people who need pain relief. (Related article: Pain relief medication guide)

A new American Heart Association science advisory on the use of COX-2 inhibitors and other non-steroidal anti-inflammatory drugs (NSAID) suggests this simple rule of thumb: Use the drug with the fewest known risks. This rule means that potent drugs like the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdecoxib) should be "held in reserve, generally for short-term use," said Joel S. Bennett, M.D., a hematologist and a member of the writing group that drafted the advisory. (Related article: Americans abandon Vioxx, Celebrex, and Bextra after safety concerns)

The association advisory comes in response to several reports that COX-2 inhibitors increase cardiovascular risks. Due to these risks, Vioxx was recalled in September by Merck, though in a bizarre development in February, a FDA panel filled with several Merck insiders recommended that Vioxx be allowed to resume sales in the US. Celebrex and Bextra continue to be on the market despite the risks.

Bennett, who is a professor of medicine at the University of Pennsylvania, explained that COX-2 drugs were developed with the idea of "having a good pain reliever that wouldn't upset the stomach, which sounded great." But that good idea was questioned when reports surfaced that long-term use of one of the drugs, rofecoxib (Vioxx), was associated with increased heart attacks and strokes. (Related article: Merck did not want Vioxx label changes to highlight risks)

The American Heart Association advisory recommends physicians weigh the benefits and risks before prescribing Celebrex or Bextra. Because the risks of adverse effects of COX-2 inhibitors are likely greatest in patients with - or at high risk for - cardiovascular disease, the statement suggests limiting the use of COX-2 drugs to those who have no appropriate alternatives. The lowest recommended dose should be given for the shortest duration necessary. (Related article: Louisiana Medicaid restricts Celebrex and Bextra prescriptions)

The advisory also addresses the use of other popular pain relievers such as aspirin and ibuprofen (Advil, Motrin). Consumers are warned that all over-the-counter drugs should be used in strict accordance with label directions and that if an over-the-counter NSAID is needed for more than 10 days, consult a physician. (Related article: Treatment options for Vioxx patients)

"We are recommending that patients use some common sense in selecting a medication to treat pain," Bennett said. "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." Medications such as aspirin and acetaminophen (Tylenol) in recommended doses and durations have minimal toxicity, which makes them good first choices, he said. "If those medicines don't work, try a stronger NSAID such as naproxen (Aleve)." Bennett noted that low-dose aspirin is recommended to reduce the risk of second heart attacks and that many people having a heart attack are given aspirin to limit heart muscle damage. (Related article: Doctors lose trust in FDA after Vioxx, Celebrex, and Bextra controversy)

Related articles

Natural alternatives to Vioxx, Celebrex, and Bextra

Non-English speakers never told of Vioxx risks

Merck manipulated FDA in Vioxx recall process

FDA did not disclose conflicts of interest in Cox-2 hearings

The advisory is published in Circulation: Journal of the American Heart Association. The advisory affirms the cautions issued by the U.S. Food and Drug Administration (FDA) in February 2005 and its co-authors are Alan Daugherty, Ph.D.; David Herrington, M.D., M.H.S.; Philip Greenland, M.D.; Harold Roberts, M.D., and Kathryn A. Taubert, Ph.D.