PHARM.D

FDA Approvals: Infliximab for Pediatric Ulcerative Colitis Clinical Context The US Food and Drug Administration (FDA) approved infliximab ( Remicade , Janssen Biotech) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have not responded adequately to conventional therapy. Infliximab is an immune system modulator that blocks the activity of tumor necrosis factor (TNF)-α, which causes inflammation and triggers autoimmune diseases. The FDA has previously approved infliximab to treat adults with UC, and adults and children older than 6 years with Crohn's disease. It is also indicated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in adults. The FDA has now extended the UC indication to children older than 6 years. Study Synopsis and Perspective The FDA approved infliximab ( Remicade , Janssen Biotech) to treat moderately to severely active UC in children older than 6 years who ha...

Breast-Feeding Lowers Risk for Sudden Infant Death Syndrome Laurie Barclay, MD Breast-feeding, particularly exclusive breast-feeding, is associated with a lower risk for sudden infant death syndrome (SIDS) according to the results of a  meta-analysis  reported online June 13 in  Pediatrics . "Benefits of breastfeeding include lower risk of postneonatal mortality," write Fern R. Hauck, MD, MS, from the Department of Family Medicine, University of Virginia School of Medicine in Charlottesville, and colleagues. "However, it is unclear whether breastfeeding specifically lowers ...SIDS risk, because study results have been conflicting." The goal of this meta-analysis was to evaluate the relationship between breast-feeding and SIDS. A Medline search from 1966 to 2009, as well as a search of bibliographies of review articles and meta-analyses, identified 288 studies with data on breast-feeding and SIDS. Of 24 original case-control studies examining the association betw...