Most research on the safety of azithromycin in pregnancy suggests it doesn't increase risks for pregnant women or developing fetuses. The number of studies is small and the participants in such studies limited, however, so it is possible the medication may cause problems that have not been uncovered with research. This is a common issue with evaluations of the safety of drugs for pregnant women. Studies on drug safety in this situation tend to involve small groups, and the limited sample size can make it easy to miss potentially serious side effects.
The Food and Drug Administration (FDA) in the United States classifies azithromycin in pregnancy as Category B. This means animal studies on the drug show no adverse effects for developing fetuses or their mothers, and there are not enough human studies to pronounce the drug categorically safe. Care providers should prescribe the drug after careful consideration and may use it if no safe alternatives are available. Azithromycin can also be an issue during breastfeeding, as it is excreted in milk.
This medication is a long-acting antibiotic that may be used to treat a range of bacterial infections. Such infections pose a clear risk at any time, but especially while patients are pregnant. As a result, a doctor may determine that the benefits of prescribing azithromycin in pregnancy outweigh the risks of not treating the patient. Alternative medications may not be as effective, or a patient could have existing drug allergies or potential drug conflicts that make them unsafe for use.
Studies on populations of women who used azithromycin in pregnancy show that the drug did not increase the risk of birth defects or complications for maternal health. In these groups, the rate of birth defects was similar to that of the general population, which ranges between one and three percent. These results suggest that azithromycin is probably safe for use in pregnancy, especially when courses of the medication are kept as short as possible. Patients should also receive routine prenatal care to monitor for any pregnancy complications.
Those with concerns about azithromycin in pregnancy can discuss them with their doctors. An obstetrician may have specific concerns about a particular pregnancy that might preclude the use of this medication. Patients should also be aware that if they have a history of miscarriages, or a high risk pregnancy, it may be possible to miscarry. If they take the medication and experience a miscarriage, they can request testing to determine the likely cause of the pregnancy loss. If no clear cause can be identified and azithromycin may have been involved, they can discuss the option of reporting the event to a database on adverse drug reactions.