USE OF AZITHROMYCIN IN PREGNANCY

Azithromycin is a macrolide antibiotic, indications include sinusitis, otitis media, pharyngitis, tonsillitis, bronchitis, pneumonia, skin and soft tissue infections, chlamydia, and gonorrhoea.

Most studies investigating malformation risk following azithromycin use in pregnancy do not provide evidence of an association. A single study has described increased risks of specific malformations, including atrioventricular septal defects and syndactyly; however, further investigation is required as these findings may have been impacted by methodological biases and/or confounding by indication and therefore do not provide compelling evidence of a causal association.

The available data relating to miscarriage and preterm delivery do not suggest increased risks following gestational exposure to azithromycin. There are no studies investigating the risk of intrauterine death, low birth weight, neonatal complications, or neurodevelopmental impairment following the use of azithromycin 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 premature rupture of membranes (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 azithromycin 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.