E-DRUG: Teratogenic effect of misoprostol

[Jerome Sclafer <jeromjet@easynet.fr>]

E-drug: Teratogenic effect of misoprostol
-----------------------------------------

The New England Journal of Medicine -- June 25, 1998 -- Volume 338, Number 26

Use of Misoprostol during Pregnancy and Mobius' Syndrome in Infants

Anne L. Pastuszak et al.

Abstract

Background. Patients with upper gastrointestinal ulceration may be treated
with misoprostol, but it is not recommended for pregnant women because it
may stimulate uterine contractions and cause vaginal bleeding and
miscarriage. Recent data from Brazil, where misoprostol is used orally and
vaginally as an abortifacient, have suggested a relation between the use of
misoprostol by women in an unsuccessful attempt to terminate pregnancy and
Mobius' syndrome (congenital facial paralysis) in their infants.

Methods. We compared the frequency of misoprostol use during the first
trimester by mothers of infants in whom Mobius' syndrome was diagnosed and
mothers of infants with neural-tube defects in Brazil. All diagnoses in
infants were made between January 16, 1990, and May 31, 1996, by clinical
geneticists at seven hospitals who also interviewed the mothers and
recorded information about the administration of misoprostol, among other
data.

Results. We identified 96 infants with Mobius' syndrome and matched them
with 96 infants with neural-tube defects. The mean age at the time of the
diagnosis of Mobius' syndrome was 16 months (range, 0.5 to 78), and the
diagnosis of neural-tube defects was made within 1 week of birth in most
cases. Among the mothers of the 96 infants with Mobius' syndrome, 47 (49
percent) had used misoprostol in the first trimester of pregnancy, as
compared with 3 (3 percent) of the mothers of the 96 infants with
neural-tube defects (odds ratio, 29.7; 95 percent confidence interval, 11.6
to 76.0). Twenty of the mothers of the infants with Mobius' syndrome had
taken misoprostol only orally (odds ratio, 38.8; 95 percent confidence
interval, 9.5 to 159.4), 20 had taken misoprostol both orally and
vaginally, 3 had taken the drug vaginally, and 4 did not report how they
took the drug.

Conclusions. Attempted abortion with misoprostol is associated with an
increased risk of Mobius' syndrome in infants. (N Engl J Med 1998;338:1881-5.)


J�r�me Sclafer <jeromjet@easynet.fr>
M�decin g�n�raliste - R�dacteur
La revue Prescrire
BP 459 - 75527 Paris Cedex 11 - France
Tel: +33 (0)1 4700 9445
Fax: +33 (0)1 4807 8732 

[This study confirms earlier case reports published in The Lancet some
years ago that the (mis)use of misoprostol for abortion could be related
to congenital malformations when the abortion was not succesful.
Misoprostol is often used by desparate women or health workers in 
countries where abortion is illegal. It results in 60-80% succesful 
terminations, depending on dosis and gestation, but also in a lot of 
painful contractions, bleeding and incomplete abortion. 

Misoprostol has also been proposed for cervical ripening before surgical abortion
(making the abortion a bit safer as the risk of perforation reduces), 
or in combination with other medication (mifepristone) for chemical abortion. 

None of the abortion indications have been accepted by the original manufacturer 
(off-label use). 

Morale: safer methods for abortion should become available to 
women; if misoprostol is used, it should always be ensured that the
pregnancy is terminated by other methods.  WB]

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