FDA Panel Backs New Leukemia Drug
A U.S. Food and Drug Administration advisory panel on Friday recommended approval of a new drug that treats certain leukemias when other treatments have failed, the Associated Press reported.
The drug, known as Sprycel, would be used to treat chronic myeloid leukemia (CML) in patients who have developed a resistance or intolerance to Gleevec. CML represents 14 percent of all adult leukemias, according to the FDA.
Bristol-Myers Squibb, which makes Sprycel, also got the panel's blessing to use the drug to treat Philadelphia chromosome-positive acute lymphoblastic leukemia, the AP reported.
The FDA is expected to decide whether to approve Sprycel by June 28; the advisory panel met in Atlanta to coincide with the American Society of Clinical Oncology (ASCO) annual meeting, which is being held in that same city.
Scios to Conduct Safety Review of Heart Drug Natrecor
Scios Inc., a division of Johnson & Johnson, said Thursday that it would spend more than $100 million to conduct a safety study of its controversial heart-failure drug, Natrecor.
The trial seeks to address safety issues concerning the drug since last year. Other studies had suggested that Natrecor, an intravenous drug approved in 2001 that was designed to treat breathing problems that can accompany heart failure, could lead to increased risk of kidney problems and a higher risk of mortality within the first month of treatment, the Associated Press reported.
Patient enrollment is expected to begin early next year and involve 7,000 people in the United States, Canada and Europe, according to Scios. The company has yet to select the lead researchers, and said it doesn't know how long the trial will take to complete, AP reported.
Clot-Busting Drug Helps Revive Cardiac-Arrest Patients
Emergency room doctors were able to double the number of patients who could be revived from cardiac arrest after using a "clot buster" drug normally reserved for treating patients during a heart attack, according to a study in the June issue of Resuscitation.
The pilot study involved patients with cardiac arrest who didn't respond to standard therapy. Of 50 patients who received the clot-buster tenecteplase, known medically as a fibrinolytic agent therapy, 26 percent were revived, compared to 12 percent of patients who got standard therapy alone. However, not all patients who were revived lived long enough to be discharged from the hospital, according to the study.
Sudden loss of heart function occurs in more than 260,000 people a year nationwide and at least 93 percent of them die, according to the report. Standard treatment for cardiac arrest is Advanced Cardiac Life Support (ACLS) measures, which include cardiopulmonary resuscitation (CPR), drugs such as adrenaline, and defibrillation, an electric shock to the heart.
"Clot-busting agents show promise as a new therapy for this abrupt and catastrophic loss of heart function," said study author Dr. William P. Bozeman, an emergency medicine specialist at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. "We are in dire need of additional treatment options for sudden cardiac arrest, because there is only a 5 percent to 7 percent survival rate using interventions we now have."
Genital Cutting Raises Death Risk for Mothers, Babies: Study
The practice of female genital cutting -- also called female circumcision -- raises the likelihood by more than 50 percent that the woman or her baby will die, according to research published Friday in The Lancet.
Serious medical complications surrounding childbirth, such as bleeding, also rose substantially in women who had undergone the procedure, the report added. More than 100 million women worldwide have undergone genital cutting, mostly in childhood. Often performed without anesthesia or sterile technique, its immediate results are pain, bleeding, infection and a risk of urinary infection, according to doctors.
"Finally, we have data to prove what health workers have long known: That female genital mutilation is a health issue, a killer of women and children, as well as a human-rights issue," Adrienne Germain, president of the International Women's Health Coalition, told The New York Times.
Female genital cutting varies in severity, from full removal of the clitoris and labia to a lesser procedure in which only the clitoris is removed. In some African cultures, genital mutilation is considered a coming-of-age ceremony. Its supporters have contended that it is a cultural practice -- like male circumcision among Jews -- with few long-term health consequences.
Restaurants Urged to Trim Portion Sizes
A U.S. government-commissioned report released Friday suggests restaurants are in prime position to both improve diets and combat obesity by serving smaller portions and adding more fruit and vegetable dishes to their menus.
Funded by the U.S. Food and Drug Administration, the 136-page report said Americans now consume fully one-third of their daily intake of calories outside the home in the nation's nearly 900,000 restaurants and other establishments that serve food, the Associated Press reported.
The top three restaurant favorites? Burgers, fries and pizza.
An estimated 64 percent of Americans are overweight, including the 30 percent who are obese, according to the report. It pegged the annual medical cost of the problem at nearly $93 billion.
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