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NTP-CERHR EXPERT PANEL REPORT ON REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF METHYLPHENIDATE.
Citation:
GOLUB, M. S., L. COSTA, K. M. CROFTON, D. FRANK, P. FRIED, B. GLADEN, R. HENDERSON, E. LIEBELT, S. LUSSKIN, S. MARTY, A. ROWLAND, J. SCIALLI, AND M. VORE. NTP-CERHR EXPERT PANEL REPORT ON REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF METHYLPHENIDATE. Birth Defects Research. Wiley Liss, New York, NY, 74(Part B):300-381, (2005).
Impact/Purpose:
To report on an expert panel meeting of the NTP Center for the Evaluation of Risks to Human Reproduction on a stimulant used in children (Methylphenidate)
Description:
A manuscript describes the results of an expert panel meeting of the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR). The purpose CERHR is to provide timely, unbiased, scientifically sound evaluations of human and experimental evidence for adverse effects on reproduction and development caused by agents to which humans may be exposed. Methylphenidate was selected for evaluation because of widespread usage in children, availability of studies on developmental effects in children and experimental animals, and public concern about the effects of these stimulants on child development. Methylphenidate is a central nervous system stimulant approved by the Food and Drug Administration for the treatment of ADHD and narcolepsy in persons six years and older. This report is a product of the Expert Panel and is intended to (1) interpret the strength of scientific evidence that methylphenidate is a reproductive or developmental toxicant based on data from in vitro, animal, or human studies, (2) assess the extent of human exposures to include the general public, occupational groups, and other sub-populations, (3) provide objective and scientifically thorough assessments of the scientific evidence that adverse reproductive/developmental health effects may be associated with such exposures, and (4) identify knowledge gaps to help establish research and testing priorities to reduce uncertainties and increase confidence in future assessments of risk. The report concludes there is a substantial published database of studies designed to investigate the potential adverse reproductive and developmental effects of methylphenidate exposure in both humans and laboratory animals. However, thorough review of these numerous studies led the Expert Panel to judge that the data were generally insufficient to reach valid scientific conclusions with regard to possible reproductive or developmental effects.