Contemporary Pediatrics - September 2008 - (Page 39)

News Updates Child cold medications to undergo standards revision The US Food and Drug Administration (FDA) announced it would revise criteria for over-thecounter (OTC) cough and cold medications for children, reported The Washington Post. The FDA will hold a hearing on October 2 to investigate the issue further, such as what studies need to be conducted to evaluate the medications, whether the treatments should be available without a prescription, and how doses should be determined. In October, a joint meeting of the FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee was held to review safety and efficacy concerns of child OTC cough and cold products. The committees recommended against the use of these products in children younger than 6, due to a lack of proven effectiveness and the need for pediatric clinical trials. BPA meeting scheduled The FDA announced that it would hold a public meeting regarding the safety of bisphenol A (BPA) on September 16, according to Reuters. This April, Health Canada isued a report that found the amount of BPA exposure in plastic products such as baby bottles is unsafe for newborns and infants, and moved to ban the chemical. However, the FDA stated in May that according to its assessment, the exposure to BPA in these products is well below the levels that would cause adverse health effects. NeoChild receives warning letter The FDA has issued a warning letter to NeoChild for alleged misbranding of its neonatal devices and procedural errors. The FDA stated that the firm marketed its SafeChild System’s enteral feeding tubes and extension sets before filing a premarket approval or getting 510(k) clearance. In addition, the July 29 letter stated that the silicone and polyurethane enteral feeding tubes and the PVC extension sets were not approved for an investigational device exemption. In addition, the FDA also cited NeoChild for failure to develop or implement written medical device report procedures from the time it started distributing devices in March 2007 to the date of an April 2008 inspection. Drug approval announced IMAGE: GETTY IMAGES. PHOTODISC RYAN MCVAY The FDA has approved the inclusion of efficacy, safety, and dosing data for patients ages 3 months to 17 years in the label for Merck’s Cancidas (caspofungin acetate). The expanded labeling makes Cancidas the first echinocandin therapy approved in the US for pediatric patients with indicated fungal infections, according to Merck. SEPTEMBER 2008 CONTEMPORARY PEDIATRICS 39

Table of Contents Feed for the Digital Edition of Contemporary Pediatrics - September 2008

Contemporary Pediatrics - September 2008 Contents Editorial Your Voice Clinical Tip News Updates Eye on Washington Puzzler Dermatology: What’s your Dx? Behavior Cover Story: ECC Epidemic Parent Guides Discipline Techniques: The 12-Month-Old Exercise-induced Bronchospasm: Keeping Our Patients Active Food Safety Parent Guide CPR--Food Safety Malnutrition Links Surgeon General Links Hospice Links Childhood Cancer Links Rx for a Healthy Practice Rx for a Healthy Practice New Products Author Guidelines Journal Club Events Calendar Classifieds Index of Advertisers Postscript

Contemporary Pediatrics - September 2008

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