A research study published online recently in PLOS One reports a slightly increased risk of epilepsy or cerebral palsy for children whose mothers take macrolide antibiotics during pregnancy.
The study, from the University College London Institute of Child Health (ICH) follows examined evidence of harm associated with prenatal antibiotics provided by a single large trial (n > 4,000) of prophylactic antibiotics for women in preterm labor. The authors analyzed a cohort of 195,909 women to determine the risk of cerebral palsy or epilepsy in children whose mothers were prescribed antibiotics during pregnancy, Pharmaceutical Journal reports.
Ruth Gilbert, professor of clinical epidemiology at ICH, led the study. Gilbert says the study’s findings add weight to concerns over this class of antibiotics, which includes Erythromycin, azithromycin, and clarithromycin. But she also notes that patients could face significant harm from an infection and this could be more significant than the risk posed by antibiotics. Gilbert says, “we need to consider whether we should recommend alternatives,” according to Pharmaceutical Journal.
The researchers found a slightly increased risk of cerebral palsy or epilepsy in the children of mothers who took macrolides compared with those who took penicillin. The incidence of cerebral palsy or epilepsy in children whose mothers took macrolides was 254.6 per 100,000 child-years-at-risk, as compared with 143.6 in children whose mothers took penicillin, Pharmaceutical Journal reports. The children were followed from birth to a median of 3.6 years.
The director of vigilance and risk management of medicines for the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), urged caution in considering the study’s findings. “The suggestion of a risk with the use of macrolide antibiotics during pregnancy should be treated with great caution,” June Raine says. The conclusion lacks information on the type and seriousness of the infection. Raine said independent experts confirmed for the MHRA that “the study is insufficient to suggest that use of macrolides in pregnancy is associated with a particular risk.”
Gilbert says the study’s findings should be viewed in context. “There is now a large body of evidence of adverse effects of macrolides in different populations, during pregnancy and in adults,” according to Gilbert. “There are three very large database studies in adults showing an association between macrolides and cardiac deaths and cardiac events.” Though it is a “very rare, low risk,” it is still a risk.
Gilbert says there is an “accumulation of signals” that needs to be considered by regulators, including a 2005 Swedish study that reported a link between erythromycin use by pregnant women and cardiovascular malformations in infants. Based on these findings, several Scandinavian countries recommended against prescribing the drug to pregnant women, according to Pharmaceutical Journal. Gilbert says the question is whether the evidence is strong enough for patients to be cautioned, particularly since there are alternative treatments.