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This week, drug maker Sanofi-Aventis sent a letter to healthcare professionals outlining the various warning and prescription changes related to their antibiotic Ketek. The changes, mandated last month by the U.S. Food and Drug Administration (FDA), include a revision of approved indications for usage along with a variety of health-risk warnings.

According to the company, “The prescribing information has been revised to add a boxed warning and contraindication for myasthenia gravis patients. In addition, the indications for the treatment of acute exacerbation of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS) have been removed from the labeling. These revisions follow discussions with the Food and Drug Administration (FDA) regarding its decision to follow recommendations of a December 2006 Advisory Committee that the balance of the benefits and risks no longer support continued marketing of Ketek for these two indications. It is important to note that Ketek continues to be indicated only for the treatment of community-acquired pneumonia (CAP) of mild to moderate severity.”
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A highly anticipated new study has called into question the long-term effectiveness of stents in the treatment of stable coronary artery disease. Researchers have determined that the use of drug therapy (including blood-pressure and cholesterol drugs) is just as effective in preventing heart attacks or death when compared to a combination of drug therapy and stent implantation. The study results were shared this week at the American College of Cardiology’s (ACC) annual Scientific Session and will be published next month in the New England Journal of Medicine (NEJM).

The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study included 2,287 angina (acute chest pain due to poor blood flow) patients with at least a 70 percent artery blockage in the U.S. and Canada and assigned each patient into one of two study arms: percutaneous coronary interventions (PCI) and optimal medical therapy (OMT) together or OMT alone. Researchers, led by cardiologist Dr. William Boden of Buffalo General Hospital in New York, followed patients for two-and-a-half to seven years, and results of the study showed a similar rate of death, heart attack, or stroke. “As an initial management strategy in patients with stable coronary artery disease,” the authors concluded, “PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.”
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A large, ongoing studied by the U.S. National Institutes of Health (NIH) has found that there are links between the quality of early child care and the child’s vocabulary development. In addition, however, the study has also determined that children who spent more time in child-care centers at a young age are more likely to develop behavioral issues. The latest study report appears in the new issue of Child Development.

The study, known as the National Institute of Child Health and Human Development (NICHD) Study of Early Child Care and Youth Development, examined more than 1,300 children to determine the effects of early child care on children’s functioning from 4½ years through the end of 6th grade. According to the authors of the latest report, which is being led by Dr. Jay Belsky of Birkbeck University in London, “The results indicated that although parenting was a stronger and more consistent predictor of children’s development than early child-care experience, higher quality care predicted higher vocabulary scores, and more exposure to center care predicted more teacher-reported externalizing problems.”
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