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Published on Nov 17, 2006 by Edgar Snyder

FDA Panel to Review Safety of Drugs in Children


The Food and Drug Administration’s (FDA) pediatric advisory committee met to review safety reports on various drugs. The panel is reviewing 16 drugs to determine if they should be used in pediatric patients.

The eight drugs that raise questions about safety include:

  • Pfizer’s Zyvox
  • GlaxoSmithKline PLC’s Zofran and Avandia
  • Forest Laboratories Inc.’s Celexa
  • Novartis AG’s Trileptal
  • Wyeth’s Rapamune
  • Abbott Laboratories’ Norvir

Eight other drugs under review are not expected to raise any concerns. The panel will make recommendations that could include label changes or further studies into the adverse events the drugs may cause in children.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Ohio, and West Virginia and we associate with experienced attorneys in other states. In addition, all drug-related litigation involves co-counsel.

Source: “FDA Panel Set to Issue Opinions On Safety of 16 Drugs in Children.” By Patricia Kowsmann. The Wall Street Journal. November 16, 2006.
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