Health & Medicine
Health Watch: Another Popular Painkiller Gets the Government's Hook
Bextra became the latest drug pulled from the market last week, as the Food and Drug Administration issued a far-reaching warning about a large class of painkillers known as nonsteroidal anti-inflammatories. NSAIDs include everything from common pain medications like ibuprofen and naproxen to the newer cox-2 inhibitors, such as Bextra and Vioxx, the drug pulled off shelves last fall because of safety risks. These drugs, says the FDA, could increase a person's risk of cardiovascular problems or gastrointestinal bleeding. "We do believe that these risks are a class effect, which means that they are shared by all of the products," says Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research.
Bextra has risks similar to that of other prescription NSAIDs, but it also showed risk of serious skin disease. That, says Galson, was what compelled the agency to ask Pfizer, the manufacturer, to pull the drug. With Bextra gone, Celebrex is the only cox-2 inhibitor still for sale. That drug and all other prescription NSAIDs will receive a black-box warning, the FDA's strongest risk warning. Nonprescription drugs in this class, which includes Advil, Motrin, and Aleve, will have to add milder warnings to their labels. Aspirin was not included in this advisory.
When Vioxx was pulled last fall, it sparked a review of both the safety of some painkillers and the FDA's process for evaluating drug risks. Last week's announcement is the culmination of that review, though as Galson puts it, "this is not likely to be the last word you hear on this subject."
Health Watch: A Scary New Bug Goes Downtown
A Scary New Bug Goes Downtown
Most doctors think the superbug called MRSA (for methicillin-resistant staphylococcus aureus ) attacks only people who have recently been in hospitals or nursing homes, where it is rampant.
But now, skin and soft tissue infections caused by MRSA have been showing up among high school athletes, children in day-care centers, prisoners, and others never believed vulnerable to the germ. The fear is that garden-variety staph, which lives on skin and in the noses of healthy people, will be supplanted by MRSA, making staph more dangerous and difficult to treat.
In a study published in last week's New England Journal of Medicine, researchers found that 8 to 20 percent of MRSA samples were from people with drug-resistant staph infections contracted outside healthcare facilities. A quarter of the patients had to be hospitalized.
Scott Fridkin, the lead author, says doctors have to change the way they treat skin infections. "They need to consider that drug-resistant staph is the possible pathogen, and this is new."
Health Watch: Kidneys, Genes, And Heart Disease
Patients with end-stage kidney disease also face a much higher risk of heart disease. Scientists say they've uncovered a pathway that could explain this: a previously unknown protein that may act as a powerful modulator of cardiovascular function. They combed through 114 genes, looking for ones that would be particularly active in the kidneys. A deficiency of one (now dubbed renalase) looks like the culprit.
Renalase appears to help metabolize excess adrenaline, a hormone that jump-starts heart rate and blood pressure and can prompt heart attacks. Yale University's Jianchao Xu, lead author of the paper in the Journal of Clinical Investigation, speculates that renalase may someday offer a treatment for the country's No. 1 killer, heart disease.
This story appears in the April 18, 2005 print edition of U.S. News & World Report.
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