MedWatch Upgrade Urged by FDA's Pediatric Advisory Panel

▸ Panel Recommendation: The panel concurred.

Atovaquone-Proguanil (Malarone Pediatric).

▸ Approved: July 14, 2000, manufactured by GlaxoSmithKline

▸ Indication: An antimalarial used in the treatment of Plasmodium falciparum malaria in patients over 5 kg and prophylaxis in patients over 1 kg.

▸ Pediatric Adverse Events Reported: Seven AEs were reported during the 1-year postexclusivity period (six serious, no deaths). There were 17 AEs reported since the drug's approval (15 serious, 3 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel unanimously concurred.

Nelfinavir Mesylate (Viracept).

▸ Approved: March 14, 1997, manufactured by Pfizer Inc.

▸ Indication: A protease inhibitor indicated for the treatment of HIV infection in patients over 2 years of age. Accounted for about 16.4% of the 1.9 million prescriptions dispensed in this drug class from Sept. 2003 to Aug. 2004.

▸ Pediatric Adverse Events Reported: There were 377 AEs reported since the drug's approval (374 serious, 19 deaths). During the 1-year postexclusivity period, there were 30 AEs reported (30 serious, 2 deaths).

▸ FDA Recommendation: Return to routine monitoring.

▸ Panel Recommendation: The panel agreed.n