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FDA Reviewing Preliminary Safety Information On Asthma Drug Xolair

The U.S. Food and Drug Administration announced that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.
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ACOG Issues New Guidelines On Fetal Monitoring To Resolve Inconsistencies In Interpretation

The American College of Obstetrics and Gynecology recently published new guidelines on electronic fetal monitoring in an attempt to increase consistency in the way physicians interpret and act on the results, the New York Times reports. Electronic fetal monitoring, which was introduced in the 1970s, is used during labor for more than 85% of the four million infants born alive in the U.S. annually, the Times reports. According to the Times, use of fetal monitors became standard obstetrical practice before it was known if the benefits outweighed the risks. The new guidelines refine the meaning of various readings from fetal monitors and could help doctors make better decisions about whether to intervene during labor.According to experts, the widespread adoption of fetal monitoring has produced both negative and positive consequences, including significant increases in caesarean deliveries and the use of forceps during vaginal deliveries. Monitoring has not been found to reduce the risk of either cerebral palsy or fetal death resulting from inadequate oxygen to the fetal brain, as it was intended to do. Furthermore, lawyers commonly use monitoring results to support malpractice cases that might have little merit, which in turn has driven rising malpractice insurance costs and prompted some obstetricians to stop delivering infants.The new guidelines divide monitor readings into three categories to help doctors interpret readings more consistently. The old guidelines had two categories -- reassuring and non-reassuring -- and it was up to the obstetrician to determine whether a non-reassuring reading required intervention. Under the new guidelines, the first category applies when tracings of the fetal heart rate are normal and no specific action is required. The second category is for indeterminate tracings that require evaluation, continuous surveillance and re-evaluation. Obstetricians treating patients in this category should consider other clinical factors that could affect the fetus and whether the patient could be safely moved to category one, according to Catherine Spong of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which produced recommendations on which the guidelines are based. The final category is for abnormal tracings that require immediate evaluation and efforts to reverse the abnormal heart rate. The Times reports that more refinements to the guidelines are expected to be released in 2010 (Brody, New York Times, 7/7).