USE OF SPIRAMYCIN IN PREGNANCY

Spiramycin is a macrolide antibiotic that is not licensed in the United Kingdom. It is used to treat toxoplasmosis and may reduce the risk of transmission of maternal infection to the fetus.

Only two studies have investigated the risk of malformation following exposure to spiramycin in pregnancy. The limited available data do not show an increased risk of congenital malformation overall and there is no compelling evidence for specific anomalies, and although one study has shown an increased risk of hydrocephaly and spina bifida, this does not provide compelling evidence of a causal association; further research is required.

The limited available data do not suggest an increased risk of miscarriage following gestational exposure to spiramycin; however, further studies are required to confirm this finding. There are no studies investigating the risk of intrauterine death, low birth weight, preterm delivery, neonatal complications, or neurodevelopmental impairment following the use of spiramycin during pregnancy; however, data do not suggest increased risks of these outcomes following gestational exposure to macrolide antibiotics as a class.

At the time of writing, the Royal College of Obstetricians and Gynaecologists (RCOG) advise routine intrapartum antibiotic prophylaxis for all women in preterm labour, with or without PROM. Benzylpenicillin should be used preferentially but substituted for a cephalosporin in patients with a non-severe penicillin allergy, or vancomycin where the allergy is severe. The National Institute for Health and Care Excellence (NICE) guidelines also state that women with pre-labour PROM should be offered oral erythromycin (250mg, 4 times a day) for a maximum of 10 days or until the woman is in established labour (whichever is sooner), with oral penicillin offered to patients who cannot tolerate erythromycin.

It is important to effectively treat infections in pregnancy as adverse maternal and fetal effects may result from uncontrolled infection or pyrexia.

Where possible, the results of culture and sensitivity tests should guide treatment choice in accordance with local prescribing guidelines. If a macrolide is indicated, erythromycin has historically been preferred during pregnancy because there is more documented experience of its use than for other macrolides. However, treatment choices should be made on a case-by-case basis accounting for likely efficacy and tolerability, as well as possible fetal effects.

Exposure to spiramycin at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.