FDA panel recommends pharmacovigilance for certain medications, vaccines

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, including the 13-valent pneumococcal conjugate vaccine (Prevnar13, Wyeth) and bivalent HPV vaccine (HPV2; Cervarix, GlaxoSmithKline). An increased risk for febrile seizure was reported with concomitant administration of the 2010-2011 influenza vaccine (Fluzone, Sanofi-Pasteur) and PCV13 in children aged 6 to 59 months, with the highest risk found in children aged 12 to 23 months. In addition, there were four reports of hypotonic-hyporesponsive episodes that occurred after licensure that the panel agreed warrants further study. As such, the panel recommended further refinement of febrile seizure risk and continued routine pharmacovigilance when administering these vaccines.

The panel also recommended similar measures for Cervarix, after hearing pre- and post-licensure safety data for HPV2. A higher rate of spontaneous abortion was found in a group of women who received HPV2 — 54 women vs. 35 in the control group. Members of the panel said although these “rates do not exceed expected rates” of spontaneous abortion in the general population, they urged further statistical evaluation analysis because cause within the first 90 days of pregnancy could not be excluded.

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