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