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The Dose

A Weekly Shot of News and Notes

Tuesday, December 14, 2004; Page HE02

DRUG RISKS, CONT'D Pfizer's painkiller Bextra, one of five drugs said by a Food and Drug Administration (FDA) official last month to have underpublicized risks, will carry a new warning about the possibility of heart attacks and blood clots in patients who have undergone heart bypass surgery.

The agency still "believes that, based on what we know now, the overall benefit of Bextra outweighs the risk when used in properly selected patients as directed in the approved labeling," the FDA said in a statement last week.

_____The Heart_____
The Druggist Is In (The Washington Post, Dec 14, 2004)
Stroke Risk Greater for Migraine Sufferers, Study Finds (Reuters, Dec 13, 2004)
Desperate for Meds (The Washington Post, Dec 7, 2004)
Safety Tests Urged For Libido Patch (The Washington Post, Dec 3, 2004)
Killer Cold Remedy (The Washington Post, Nov 30, 2004)
More Heart News

Bextra is not approved for treating pain following bypass surgery. The new warning specifically urges doctors not to use the drug in that setting.

The updated Bextra label also includes a stronger "black box" warning, about the possibility of a rare, potentially fatal skin reaction known as Stevens-Johnson syndrome. The FDA has received 87 reports of that condition and other skin reactions. Thirty-six of the patients were hospitalized and four died.

Bextra is under scrutiny because it is in the same family of drugs as Merck's arthritis pill Vioxx, which was pulled from the market Sept. 30 after a study showed the drug doubled the chances of heart attack and stroke when used for more than 18 months. Both drugs are called COX-2 inhibitors.

The FDA is planning a meeting in February to discuss safety concerns with that class of drugs, including Pfizer's Celebrex.

MOMMY, MAKE IT STOP You've got your Mediterranean Diet, the South Beach Diet, the upcoming Park Avenue Diet. And now: the Northwoods Diet. That's what University of Minnesota professor David Bernlohr, an obesity researcher, jokingly named his personal regimen.

"If the beautiful people in South Florida can have South Beach, the hardworking people of Minnesota can have Northwoods," the professor said.

His plan: Three meals a day with smaller portions and no food after 7:30 p.m. He starts with a carb-heavy breakfast such as cold cereal or oatmeal. Lunch features carbs and protein, often pizza. Dinner is heavy on protein, with meat, vegetables and salads.

The approach "is just common sense to people who study nutrition or metabolism," said Bernlohr, who says he's lost 40 pounds over the last year. But he's chagrined at the media attention.

"This is not a scientific study," he said. "It's simply a catchy name."

DECK THE FALLS About 5,800 Americans are expected to be treated in emergency rooms for falls that occur while decorating Christmas trees and hanging holiday ornaments, according to the Centers for Disease Control and Prevention.

-- From staff and wire reports


© 2004 The Washington Post Company


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