Frågedatum: 2007-12-19
RELIS database 2007; id.nr. 23393, DRUGLINE
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Can Nix (permethrin for topical administration) be given safely during pregnancy or is Tenutex (ben



Fråga: Can Nix (permethrin for topical administration) be given safely during pregnancy or is Tenutex (bensylbenzoat + disulfiram for topical administration) that is available without a prescription a better alternative?

The question concerns a pregnant woman (gestational age week 11) that suffers from scabies.

Sammanfattning: Although studies in humans are limited we have found no data of any adverse effects on the pregnancy after topical used permethrin. Studies in animals show no teratogenic effects. Most likely, permethrin for topical treatment can be used safely during pregnancy.

Svar: Permethrin is a synthetic derivate of pyretrin, a insecticide originating from plants. It is used to treat scabies and lice and is sold in Sweden as a 5% permethrin cream for topical use.

Similar questions concerning permethrin have previously been answered in Drugline (1,2). In these documents it is concluded that low exposition of permethrin during pregnancy is not associated with any adverse events (1). Studies in animals have not demonstrated any teratogenic effects or other adverse effects on the pregnancies (2).

The mean percentage absorbed from topical administrated 5% permethrin crème is less than 1% (3). The maximum value of observed percutaneus absorption of permethrin described in the literature was 2,1% (3).

In the Swedish Medical Birth Register there are no cases of permethrin treatment during early pregnancy reported. However, Prof Bengt Källén concludes that due to the low systemical exposition during topical treatment no adverse effects on the pregnancy appear likely (4).

In a retrospective case-control study from 2007 information from 196 pregnant women who have used 4% permethrin due to scabies is compared with 784 scabies-free pregnant matched controls (5). There was no difference in the pregnancy outcomes between the permethrin-treated and control women. However, 90% of the permethrin-treated women in the study have used permethrin during the second and third trimester when the organogenesis was already completed.

In a case-report from 2003 a mother who has exposed herself to extreme amounts of aerosolised permethrin due to severe arachnophobia gave birth to a child suffering from congenital leukaemia. The child died two days after labour due to multiorgan failure (6).

Questions concerning disulfiram-treatment during pregnancy have previously been answered in Drugline (7,8,9,10). The systemically exposition after topical used disulfiram has not been thoroughly studied but according to the manufacture the exposure is considered to be very low and it is unlikely to be of any risk for the fetus (8,9,10). We have found no new information considering topical use of disulfiram during pregnancy after searching in Medline. In the Swedish Medical Birth Register there are 59 children whose mothers have been taking disulfiram systemically as an alcohol deterrent (Antabus) during early pregnancy. None of these children were born with any malformations (4). However, in the literature there are some case-reports of malformations in infants born to mothers treated with disulfiram per os (4,7).

Referenser:
  1. Drugline no 13255 (year 1997)
  2. Drugline no 15986 (year 1999)
  3. Tomalik-Scharte D, Lazar A, Meins J, Bastian B, Ihrig M, Wachall B, Jetter A, Tantcheva-Poor I, Mahrle G, Fuhr U. Dermal absorption of permethrin following topical administration. Eur J Clin Pharmacol 2005;61:399-404.
  4. www.janusinfo.se /Läkemedel och fosterskador
  5. Mytton OT, McGready R, Lee SJ, Roberts CH, Ashley EA, Carrara VI, Thwai KL, Jay MP, Wiangambun T, Singhasivanon P, Nosten F. Safety of benzylbenzoate lotion and permethrin in pregnancy: a retrospective matched cohort study. BJOG 2007;114(5):582-7.
  6. Borkhardt A, Wilda M, Fuchs U, Gortner L, Reiss I. Congenital leukaemia after heavy abuse of permethrin during pregnancy. Arch Dis Child Fetal Neonatal Ed 2003;88(5):F436-7.
  7. Drugline no 17463 (year 2001)
  8. Drugline no 10587 (year 1992)
  9. Drugline no 07728 (year 1991)
  10. Drugline no 06533 (year 1989)