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Acyclovir in Pregnancy Registry. An observational epidemiologic approach
E B Andrews1, H H Tilson, B A Hurn
1Epidemiology, Information and Surveillance Division, Burroughs Wellcome Co., Burroughs Research Triangle Park, North Carolina 27709.
The American Journal of Medicine
|August 29, 1988
Summary
This study tracks prenatal exposure to acyclovir, an antiviral medication, to assess its safety during pregnancy. Current data is insufficient to draw conclusions on acyclovir
Area of Science:
- Pharmacovigilance
- Reproductive Epidemiology
- Antiviral Drug Safety
Background:
- Evaluating the safety of medications during pregnancy is crucial.
- Acyclovir is commonly prescribed for herpes infections.
- Baseline pregnancy outcomes in untreated women are needed for comparison.
Purpose of the Study:
- To evaluate the safety of acyclovir use during pregnancy.
- To establish expected pregnancy outcomes for women with herpes not on acyclovir.
- To present provisional data from ongoing safety studies.
Main Methods:
- Observational epidemiologic methods, including a case registration study.
- International Acyclovir in Pregnancy Registry tracks prenatal exposures.
- Data collection includes maternal exposure, risk factors, and pregnancy outcomes.
Main Results:
- Provisional data from prospective reports are summarized.
- Information on trimester of exposure and reported pregnancy outcomes is included.
- The current number of monitored pregnancies is too small for definitive conclusions.
Conclusions:
- Current data is insufficient to determine the safety of acyclovir in pregnancy.
- Further monitoring through the registry and other studies is necessary.
- The potential of ongoing studies to address safety concerns will be discussed.
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