Document Detail

Use of acyclovir, valacyclovir, and famciclovir in the first trimester of pregnancy and the risk of birth defects.
MedLine Citation:
PMID:  20736469     Owner:  NLM     Status:  MEDLINE    
CONTEXT: Herpes simplex and herpes zoster infections are common and often treated with antiviral drugs including acyclovir, valacyclovir, and famciclovir. Safety of these antivirals when used in the first trimester of pregnancy is insufficiently documented.
OBJECTIVE: To investigate associations between exposure to acyclovir, valacyclovir, and famciclovir in the first trimester of pregnancy and risk of major birth defects.
DESIGN, SETTING, AND PARTICIPANTS: Population-based historical cohort study of 837,795 live-born infants in Denmark from January 1, 1996, to September 30, 2008. Participants had no diagnoses of chromosomal aberrations, genetic syndromes, birth defect syndromes with known causes, or congenital viral infections. Nationwide registries were used to ascertain individual-level information on dispensed antiviral drugs, birth defect diagnoses (categorized according to a standardized classification scheme), and potential confounders.
MAIN OUTCOME MEASURE: Prevalence odds ratios (PORs) of any major birth defect diagnosed within the first year of life by exposure to antiviral drugs.
RESULTS: Among 1804 pregnancies exposed to acyclovir, valacyclovir, or famciclovir in the first trimester, 40 infants (2.2%) were diagnosed with a major birth defect compared with 19,920 (2.4%) among the unexposed (adjusted POR, 0.89; 95% confidence interval [CI], 0.65-1.22). For individual antivirals, a major birth defect was diagnosed in 32 of 1561 infants (2.0%) with first-trimester exposure to acyclovir (adjusted POR, 0.82; 95% CI, 0.57-1.17) and in 7 of 229 infants (3.1%) with first-trimester exposure to valacyclovir (adjusted POR, 1.21; 95% CI, 0.56-2.62). Famciclovir exposure was uncommon (n = 26), with 1 infant (3.8%) diagnosed with a birth defect. Exploratory analyses revealed no associations between antiviral drug exposure and 13 different subgroups of birth defects, but the number of exposed cases in each subgroup was small.
CONCLUSION: In this large nationwide cohort, exposure to acyclovir or valacyclovir in the first trimester of pregnancy was not associated with an increased risk of major birth defects.
Björn Pasternak; Anders Hviid
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  304     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-08-25     Completed Date:  2010-08-27     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  859-66     Citation Subset:  AIM; IM    
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MeSH Terms
2-Aminopurine / adverse effects,  analogs & derivatives*,  therapeutic use
Abnormalities, Drug-Induced / epidemiology*
Acyclovir / adverse effects*,  analogs & derivatives*,  therapeutic use
Antiviral Agents / adverse effects*,  therapeutic use
Cohort Studies
Denmark / epidemiology
Herpes Simplex / drug therapy
Herpes Zoster / drug therapy
Middle Aged
Pregnancy Trimester, First
Retrospective Studies
Valine / adverse effects,  analogs & derivatives*,  therapeutic use
Young Adult
Reg. No./Substance:
0/Antiviral Agents; 104227-87-4/famciclovir; 452-06-2/2-Aminopurine; HG18B9YRS7/Valine; MZ1IW7Q79D/valacyclovir; X4HES1O11F/Acyclovir
Comment In:
JAMA. 2010 Nov 24;304(20):2242-3; author reply 2243   [PMID:  21098768 ]
Evid Based Med. 2011 Feb;16(1):30   [PMID:  21109680 ]
JAMA. 2010 Aug 25;304(8):905-6   [PMID:  20736478 ]

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