Document Detail


Acyclovir in Pregnancy Registry. An observational epidemiologic approach.
MedLine Citation:
PMID:  3407674     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Observational epidemiologic methods are being used to evaluate the safety of acyclovir in pregnancy. An essential component of this research is the establishment of a baseline expectation of pregnancy outcomes among women with herpes not receiving acyclovir. Continuing studies will be described in this report. To supplement these structured studies, an international case registration study was established. Through the Acyclovir in Pregnancy Registry, all cases of reported prenatal exposures to acyclovir are tracked to ascertain maternal exposure, risk factor, and pregnancy outcome information. The reports originate in all countries where oral acyclovir is marketed; data consolidation and analysis are coordinated at Burroughs Wellcome Co. with the assistance of a government/industry advisory panel. This presentation summarizes provisional data from the prospective reports, including trimester of exposure and reported outcomes of pregnancy. The total number of monitored pregnancies remains too small to support conclusions about the safety of acyclovir during pregnancy at this point. The potential for the registry and other epidemiologic studies to address the safety-in-pregnancy question will be discussed.
Authors:
E B Andrews; H H Tilson; B A Hurn; J F Cordero
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The American journal of medicine     Volume:  85     ISSN:  0002-9343     ISO Abbreviation:  Am. J. Med.     Publication Date:  1988 Aug 
Date Detail:
Created Date:  1988-09-22     Completed Date:  1988-09-22     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0267200     Medline TA:  Am J Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  123-8     Citation Subset:  AIM; IM    
Affiliation:
Epidemiology, Information and Surveillance Division, Burroughs Wellcome Co., Burroughs Research Triangle Park, North Carolina 27709.
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / prevention & control*
Acyclovir / adverse effects*,  therapeutic use
Evaluation Studies as Topic*
Female
Great Britain
Herpes Simplex / drug therapy*
Humans
Pregnancy
Pregnancy Complications, Infectious / drug therapy*
Pregnancy Outcome*
Product Surveillance, Postmarketing*
Prospective Studies
Registries
United States
Chemical
Reg. No./Substance:
59277-89-3/Acyclovir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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