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FDA Approves Drug for Treating Bacterial Infection Sepsis


The Food and Drug Administration last week approved the first drug that has been shown useful for treating sepsis, a bacterial infection of the bloodstream that strikes about 750,000 Americans each year, killing 225,000 of them.

Researchers have been searching for an effective sepsis treatment for at least two decades, but the new drug, called Xigris, is the first that has been proved to show a benefit, albeit a modest one.

Clinical trials have shown that Xigris reduces deaths by about 13% in patients who are the most ill and thus at highest risk of dying.

Experts cautioned that Xigris works, in part, by interfering with blood clotting and can cause severe bleeding or strokes. The drug's manufacturer, Eli Lilly & Co., said it will be shipped to hospitals within days.

Pulmonary Hypertension Drug Gets Approval

The FDA also approved the first oral drug to treat pulmonary hypertension, a disease that causes dangerously high blood pressure in the artery connecting the heart and lungs. The potentially fatal disorder strikes one or two people per million, primarily women in their 30s and 40s.

Until now, the only available treatment was the drug prostacyclin, which is infused into the artery by a minipump through a permanently implanted tube in the chest. The device prolongs survival for about five years in 60% of patients. It is expensive, however, costing about $60,000 a year, and patients can die if the tube is blocked or the pump breaks down.

The new drug, called Tracleer, blocks a chemical called endothelin that constricts blood vessels. Although it is effective against pulmonary hypertension, Tracleer can cause liver damage and birth defects. Patients who receive the drug will require monthly tests of their liver function. Women will need monthly pregnancy tests before receiving their prescription. The drug will cost about $28,500 per year.

Flu Shots Not a Dangerto Asthma Sufferers

Many asthma patients, and some doctors, are concerned that a flu shot can trigger a dangerous asthma attack, but a new study indicates that such fears are unfounded. Because of that misconception, only about 10% of asthma patients receive a flu shot each year, risking serious illness and even death.

Between 20,000 to 40,000 Americans die of influenza each year.

Dr. Mario Castro and his colleagues at the Washington University School of Medicine in St. Louis studied 2,032 children and adults with asthma. Half received the flu vaccine and half a placebo shot. After a week, the placebo recipients received a flu shot and vice versa. Their asthma symptoms were monitored for two weeks.

The team reported in Thursday's New England Journal of Medicine that there was no difference in the likelihood of an asthma flare-up between the two groups: about 30% of the people in each group had an asthma flare-up during the week after their injection. Asthma patients often suffer such flare-ups as a result of colds, exercise or exposure to such irritants as pollen, animal dander, smoke and cold air.

"Now we know for the first time that [the vaccine] is safe to use in all asthmatics," Castro said.

Lipokinetix Can Cause Liver Damage

Consumers should immediately stop using a dietary supplement called Lipokinetix, marketed as a weight-loss product, because it can cause liver damage, the FDA said last week. The FDA said it has received six reports of liver injury or liver failure in young adults who had used Lipokinetix for periods ranging from two weeks to three months.

"No apparent cause of liver injury was identified in these reports other than use of Lipokinetix," the agency said in a statement. People taking the supplement should contact their physician if they experience nausea, fatigue, abdominal pain or change in skin color, the agency said.

Menstrual Cycle Can Be Clue to Diabetes Risk

Women who have unusually long or irregular menstrual cycles have double the normal risk of developing diabetes and should receive more frequent checkups, according to physicians from Brigham and Women's Hospital in Boston. The doctors think the unusual cycles may be symptomatic of underlying metabolic abnormalities that raise the risk of insulin resistance, the primary cause of type 2 diabetes.

Dr. Caren Solomon and her colleagues drew their findings from the Nurses' Health Study, an ongoing survey of more than 100,000 women. The team reported in Wednesday's Journal of the American Medical Assn. that women who reported their menstrual cycles were 40 days apart--contrasted with the normal 26 to 31 days--had twice the normal risk of developing diabetes. Women whose cycles were too erratic to predict also had double the normal risk.


Thomas H. Maugh II can be reached at

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