FDA Panel to Discuss Safety/Efficacy of Ipecac Syrup
05/06/2003
Federal Register Notice: FDA’s Nonprescription Drugs Advisory Committee will meet 6/12, from 8 a.m. to 5 p.m. at the Holiday Inn, Bethesda, MD. The committee will consider the safety and efficacy of ipecac syrup, indicated for emergency use to cause vomiting in poisoning, for continued OTC status under 21 CFR 201.308. The primary areas of consideration are: (1) The status of the role of ipecac syrup in gastrointestinal decontamination; (2) whether the literature clearly defines the risk/benefit ratio of ipecac syrup; (3) the role of ipecac syrup in poison treatment for populations with limited access to emergency medical treatment; (4) if there is significant abuse of ipecac syrup; and (5) alternative therapies to ipecac syrup. Contact Karen M. Templeton-Somers, (301) 827-7001. To view this notice, click here.
