E-DRUG: Use of Isotretinoin in pregnancy

[Jerome Sclafer <jeromjet@easynet.fr>]

E-drug: Use of Isotretinoin in pregnancy
---------------------------------------------

>From DrugMed list:

>I am very worried about the slowly increasing numbers of women
>getting pregnant while taking "isotretinoin", (pills or creams).
>The women affected did not use appropriate birth control methods,
>they were badly informed and finally they belong to low social
>cultural strata. Personally I am against the use of isotretinoin in
>women of childbearing age. But on the other hand, in cases of
>severe acne, they could benefit from it. The question: are there
>scientific data about the length of time after taking isotretinoin,
>in order to go for a pregnancy with a risk of malformation = general
>population? Thanks,

>Dr Nestor Nunez
>Gynecologist
>Colg 2267, Mlaga
>nnunez@lander.es 

Dear Dr Nestor,

The British National Formulary (September 1997) states that pregnancy
should be avoided for at least 1 month after cessation of isotretinoin
therapy.

>From La revue Prescrire 1997; 17(170):113-114: At the 1997 "18e
Journees francaises de pharmacovigilance", 318 cases of women who
took isotretinoin while pregnant were reported by the French
pharmacovigilance centres (267 became pregnant while on the drug or
less than one month after; 51 started the treatment although already
pregnant). Abortion was procured in 199 cases; 6 spontaneous abortion;
7 known cases of malformations. A survey conducted in pharmacies in
France, showed that although women purchasing isotretinoin had well
understood that they should not become pregnant during treatment,
only 30% had understood that they should continue contraception for
one month after cessation of treatment. 

Jerome Sclafer
La revue Prescrire
BP 459 - 75527 France Cedex 11
tel: +33 1 4700 9445
fax: +33 1 4807 8732
jeromjet@easynet.fr

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