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Pregnancy

Herpes Medications During Pregnancy Not Linked To Major Birth Defects Risk (Medical
News Today-25 August 2010)

A Danish study reports that pregnant mothers who take antiviral drugs frequently used to treat
herpes simplex and herpes zoster infections during the first trimester of pregnancy do not appear
to have an increased risk of major birth defects. The study is published in JAMA (Journal of the
American Medical Association), August 25th issue.

The authors inform that over 1% of susceptible females acquire herpes simplex during their first
trimester of pregnancy - antiviral treatments are indicated for a considerable number of such
patients during pregnancy.

The authors write:

Although the safety of acyclovir, valacyclovir, and famciclovir in general has been well
established, data on the use of these antivirals in early pregnancy are limited.

Bjorn Pasternak, M.D., Ph.D., and Anders Hviid, M.Sc., Dr.Med.Sci., of Statens Serum Institut,
Copenhagen, Denmark, carried out a registry-based study involving 837,795 live-born infants in
Denmark from Januray 1996 to September 2008, to determine whether there was any link
between acyclovir, valacyclovir, and famciclovir use in the first trimester of pregnancy and
major birth defects.

The infants did not have any diagnoses of chromosomal aberrations, genetic syndromes, birth
defect syndromes with known causes, or congenital viral infections, the researchers found.

The researchers used nationwide registries to determine individual-level data on dispensed

antiviral medications, birth defect diagnoses and factors which might influence outcomes
(potential confounders).

Among the 1,804 pregnancies in which acyclovir, valacyclovir, or famciclovir was administered
at any time in the first trimester:
2.2% (40) of the infants had a diagnosis of a major birth defect Compared to

2.4% (19,920) of the 835,991 infants among the unexposed pregnancies had a diagnosis of a
major birth defect
After adjusting for several variables, the researchers found that acyclovir, valacyclovir, or
famciclovir exposure at any time in the first trimester was not linked to a higher risk of major
birth defects.
2% of the pregnancies exposed to acyclovir, the most commonly prescribed antiviral, had major
birth defects, compared to 2.4% of the unexposed pregnancies. 3.1% of pregnancies exposed to
valacyclovir and 3.8% OF famciclovir exposures resulted in major birth defects (famciclovir use
was very uncommon).

Further analyses found no link between exposure to antiviral drugs during the first trimester of
pregnancy and 13 different subgroups of birth defects - however, the number of exposed cases
was small in each subgroup.

The authors concluded:

Our study, to our knowledge the largest of its kind, found no significant association between
first-trimester exposure to antiherpetic antiviral drugs and major birth defects. Consequently, it
has immediate clinical implications and may support informed decisions on safety when
prescribing antivirals for herpes infections in early pregnancy. Acyclovir is the most extensively
documented antiviral and should therefore be the drug of choice in early pregnancy, while data
on valacyclovir and famciclovir are still insufficient. Future research on antiherpetic antivirals
and mother-child health should include safety studies with regard to spontaneous abortion and
preterm birth, and during breastfeeding.

In an accompanying editorial, James L. Mills, M.D., M.S., and Tonia C. Carter, Ph.D., of the
National Institutes of Health, Bethesda, Md., commented:

The study by Pasternak and Hviid is helpful in demonstrating the safety of acyclovir in
pregnancy, but additional strategies must be developed to resolve the remaining issues. At a time
when the health care system in the United States is facing enormous financial challenges, it is
important not to ignore any sources of data that could answer critical medical questions.