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NTP-CERHR EXPERT PANEL REPORT ON THE REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF AMPHETAMINE AND METHAMPHETAMINE.
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 THE REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF AMPHETAMINE AND METHAMPHETAMINE. BIRTH DEFECTS RESEARCH. Wiley Liss, New York, NY, 74(Part B):471-584, (2005).
to better evaluate human and experimental evidence for adverse effects on reproduction and development
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. Amphetamines were selected for expert panel 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. d- and d,l-Amphetamine are approved by the Food and Drug Administration for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. d- Methamphetamine hydrochloride is used in pharmaceutical preparations in the United States and is approved for the treatment of ADHD and for short-term treatment of obesity. This report is a product of the Expert Panel and is intended to (1) interpret the strength of scientific evidence that amphetamines are reproductive or developmental toxicants 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 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 Expert Panel concluded that there was insufficient evidence to evaluate the developmental toxicity of therapeutic use of amphetamines in humans. There were two cohort studies in which pregnant women were prescribed amphetamines to limit weight gain during gestation that did not show statistically significant increases in overall malformations, but their power for studying malformations was low. These studies are not sufficient to draw conclusions about risk of specific malformations. There is insufficient evidence for a conclusion on the effect of gestational exposure to amphetamine on birth weight.
Record Details:Record Type: DOCUMENT (JOURNAL/PEER REVIEWED JOURNAL)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LABORATORY
NEUROBEHAVIORAL TOXICOLOGY BRANCH