Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment

1998 ◽  
Vol 5 (4) ◽  
pp. 190-191 ◽  
Author(s):  
Robbin R. Eldridge ◽  
Sara A. Ephross ◽  
Cindy R. Heffner ◽  
Patricia S. Tennis ◽  
Dr.Monika Stender ◽  
...  
2000 ◽  
Vol 182 (1) ◽  
pp. 159-163 ◽  
Author(s):  
Robbin Reiff-Eldridge ◽  
Cindy R. Heffner ◽  
Sara A. Ephross ◽  
Patricia S. Tennis ◽  
Alice D. White ◽  
...  

1998 ◽  
Vol 43 (6) ◽  
pp. 582-584 ◽  
Author(s):  
Benedetto Vitiello

With increasing frequency, psychotropic medications are being prescribed to young children, often for long periods of time. The interaction between psychotropics and the developing brain has not been systematically investigated in humans. Data collected from animals suggest that developing neurotransmitter systems can be exquisitely sensitive to early inhibition or stimulation by pharmacological agents, which can lead to permanent changes in adult life. Most of these data are collected from rodents, and their extrapolation to humans is difficult. More relevant models could be developed, for instance using primates. In humans, the focus of research has traditionally been on the possible teratogenic effects of prenatal drug exposure. Recently introduced quantitative imaging techniques can offer new approaches to studying the effects of psychotropics on the developing brain. This research has clear implications for the safety and efficacy of psychopharmacologic drug use in children.


2004 ◽  
Vol 10 (2) ◽  
pp. 89-101 ◽  
Author(s):  
Margaret B. Pulsifer ◽  
Krestin Radonovich ◽  
Harolyn M.E. Belcher ◽  
Arlene M. Butz

Author(s):  
Christof Schaefer

Pregnancy-related information provided by leaflets usually contains inadequate data to interpret risks of teratogenicity; and in the absence of data, prescribing information often recommends discontinuing use in anticipation of and during pregnancy. In contrast, individual information on drug risk assessment addresses three different clinical perspectives: 1) looking for drugs of choice or planning pregnancy under medication; 2) assessment of drugs’ risk after exposure during an unplanned pregnancy; 3) assessment of causality in cases of adverse pregnancy outcomes in association with drug exposure. Unfortunately, for many women with chronic rheumatic diseases, discontinuation of all medication leaves an unacceptable risk of disease reactivation. Although, for the majority of drugs, human data are still insufficient to rule out developmental risks it is possible to distinguish antirheumatic drugs of choice with apparently low or negligible risks from those with scarce data or controversies on their safety and those with evidenced risk for the unborn.


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