Chloramphenicol is a broad spectrum antibacterial. Due to the risk of serious haematological side effects, systemic use is reserved for the management of life-threatening infections such as those caused by Haemophilus influenzae or typhoid fever. Chloramphenicol is also used topically in the treatment of acute bacterial conjunctivitis or bacterial infection of the outer ear.
The available data do not indicate that use of ocular chloramphenicol is associated with an increased incidence of congenital malformations; however other outcomes have not been sufficiently studied to exclude a risk. An evidence-based evaluation of risk to the fetus is not currently possible for systemic use of chloramphenicol. There are concerns that use near term may be associated with a risk of neonatal Gray Baby Syndrome, however there are no well-documented cases of this occurring. Any risks to the fetus should be weighed against the potential adverse effects for the mother and fetus from an untreated infection.
Exposure to ocular chloramphenicol at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or additional fetal monitoring. Due to the lack of safety data and the severity of infection that would necessitate use of systemic chloramphenicol, additional fetal monitoring may be warranted on a case-by-case basis. Other risk factors may also 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.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.