Posted on PediatricSuperSite
The FDA’s Pediatric Advisory Committee met this week and reviewed data relating to several medications currently being used in children, in accordance with the Best Pharmaceuticals for Children Act.
The committee heard data on a number of medications and vaccinations that encompassed a variety of conditions, including attention-deficit/hyperactivity disorder, asthma and human papillomavirus infection.
The advisory committee recommended that the FDA continue surveillance and asked the FDA to consider reassessing labeling of dexmethylphenidate hydrochloride (Focalin XR, Novartis) because of one report of angioedema and anaphylaxis in a pediatric patient.
The panel also recommended continued monitoring of reports on numerous vaccines,
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