[Leflunomide: assessing teratogenic risk during the first trimester of pregnancy].
OBJECTIVE
To assess the teratogenic risk associated with leflunomide during the first quarter of pregnancy, and to establish guidelines to minimize said risk.


METHODS
Literature search using tertiary, secondary, and primary sources related to teratogenicity, including databases (MEDLINE and EMBASE) and specific webs. The information required for assessment, as well as for the establishment of criteria was collected.


RESULTS
Leflunomide demonstrated an increased risk of fetal death and teratogenic effects in animals. No major or minor malformation cases have been reported in humans regarding leflunomide, which is classified within category X of fetal risk. A wash-out regimen may possibly reduce the risk for fetal harm.


CONCLUSIONS
Conception scheduling or early pregnancy detection is required for better clinical counselling and the avoidance of unnecessary risk.
Casanova Sorní
C
C
Servicio de Farmacia, Hospital Universitario La Fe, Valencia. casanova_carsor@gva.es
Romá Sánchez
E
E
Pelufo Pellicer
A
A
Poveda Andrés
J L
JL
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects*; D000077339:Leflunomide; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D018570:Risk Assessment
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007555:Isoxazoles; D000077339:Leflunomide