BACKGROUND: We had a case in which three consecutive pregnancies resulted in birth of three children with an orofacial cleft. Their mother suffered from bronchial asthma and was treated using symbicort (corticosteroid budesonide plus bronchodilator formoterol) during her pregnancies. A hypothesis was assessed: these anti-asthmatics can induce an orofacial cleft in experimental model. MATERIALS AND METHODS: A single administration of one of five increasing doses (including therapeutically used ones) of Symbicort, budesonide or formoterol was injected into the amnion of a chick embryo on day 4 or 5 of incubation. The teratogenic/lethal effects of the anti-asthmatics were assessed on a total of 600 embryos. RESULTS: For budesonide, the teratogenic/lethal effect started at a dose 0.003 μg per embryo, for formoterol at 0.3 μg and for Symbicort 0.03 μg. Orofacial clefts and gastroschisis after exposure were found for all three anti-asthmatics. Heart septum defects occurred after exposure to formoterol. CONCLUSION: The present results support those clinical/epidemiological studies pointing out that anti-asthmatics have the potential to induce orofacial clefts, gastroschisis and heart malformations during prenatal development in human.

• Klíčová slova
• Teratology, development, drug safety, embryogenesis, reproduction,
• MeSH
• antiastmatika * MeSH
• aplikace inhalační MeSH
• budesonid škodlivé účinky   MeSH
• dítě MeSH
• dvojitá slepá metoda MeSH
• ethanolaminy škodlivé účinky   MeSH
• formoterol fumarát škodlivé účinky   MeSH
• gastroschiza * chemicky indukované   MeSH
• kombinace léků budesonid a formoterol MeSH
• kuřecí embryo MeSH
• lidé MeSH
• rozštěp patra * chemicky indukované   MeSH
• rozštěp rtu * chemicky indukované   MeSH
• srdeční septum MeSH
• výsledek terapie MeSH
• zvířata MeSH
• Check Tag
• dítě MeSH
• kuřecí embryo MeSH
• lidé MeSH
• ženské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• antiastmatika * MeSH
• budesonid MeSH
• ethanolaminy MeSH
• formoterol fumarát MeSH
• kombinace léků budesonid a formoterol MeSH