Was the withdrawal of NeutroSpec discussed with the Drug Safety Oversight Board?
The Board was told about the ongoing assessment of the observed adverse events associated with the use of NeutroSpec. • How long will this suspension last? The availability of NeutroSpec in the future will depend on the analyses of the data being obtained by the drug?s manufacturer. The FDA may require that new clinical trials be conducted to show that NeutroSpec is safe and effective before marketing resumes. • How long has the FDA known about this situation? The two reports of death following NeutroSpec administration were initially reported as possibly related to myocardial infarctions and were reported to the FDA’s Medwatch program in April and May, 2005, respectively. Periodic safety reports, submitted to the FDA in July and October, 2005 consisted of additional reports citing serious reactions also occurring within minutes of NeutroSpec injection. FDA staff has since been working with the company to obtain more information about the postmarketing safety profile in order to determ
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- Was the withdrawal of NeutroSpec discussed with the Drug Safety Oversight Board?
