Pediatric Subcommittee To Consider Neonatal Antidepressant Withdrawal June 9

[Guest guest]

Pediatric Subcommittee To Consider Neonatal Antidepressant Withdrawal June 9

FDA's Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

will advise the agency on the best methods of informing the public and

practitioners about neonatal withdrawal syndromes following gestational

antidepressant exposure during its June 9 meeting.

The pediatric subcommittee is scheduled to discuss neonatal withdrawal

following exposure to serotonin reuptake inhibitors or selective

norepinephrine reuptake inhibitors.

The subcommittee will also provide guidance on research needs in the area of

neonatal antidepressant withdrawal.

Subcommittee members have been provided with nine journal articles on

withdrawal covering such topics as the risks of neurobehaviorial outcomes in

babies born to treated mothers, the benefits of discontinuing therapy in

pregnant women and the appropriate treatment of neonatal SSRI withdrawal.

The main part of the meeting will feature presentations of pediatric adverse

event reports for Aventis' Allegra (fexofenadine), GlaxoKline's

Hycamtin (topotecan), Schering-Plough's Temodar (temozolomide), Alcon's

Vigamox (moxifloxacin) and Ciloxan (ciprofloxacin), Bristol-Myers Squibb's

Monopril (fosinopril) and Alza's Duragesic (fentanyl transdermal patch) and

Effexor (venlafaxine).

The reports will cover the first year of marketing following the granting of

pediatric exclusivity.

In addition, the subcommittee will hear updates on congenital eye

malformation in infants and on the Pediatric Research Equity Act, plus an

overview of an Institute of Medicine report entitled " Ethical Conduct of

Clinical Research Involving Children. "