At this point in time, we do not have sufficient information to make an informed decision about the safety of bilastine during pregnancy. Antihistamines are commonly used for the treatment of a number of common ailments in women of childbearing age with the most frequent being allergic rhinitis (AR) and urticaria. Indeed, it has been estimated that up to 20%–30% of women experience AR and 4%–7% suffer from asthma during pregnancy which, along with some dermatological complaints, make them some of the most common groups of medical conditions that complicate pregnancy. These illnesses might affect the wellbeing and quality of life of the mother since they can be highly debilitating, presenting with a range of symptoms such as nasal discharge, itching and nasal blockage or congestion in patients with AR and an array of dermatological complaints in patients with urticaria.
The safety of antihistamines has not been fully established during pregnancy and they should only be used if, in the doctor’s assessment, the benefits outweigh the risks.
Pregnancy labelling recommendations by the FDA are currently being revised. The old system used pregnancy safety categories A, B, C, D, and X (Table 2), which the FDA now consider confusing. These will be discontinued, and a new narrative-based system incorporating summaries of the risks of a drug during pregnancy and discussions of the data supporting the summaries will be required. The FDA believes that these changes in labelling will provide more meaningful information for clinicians. Guidance from the EMA (European Medicines Agency) requires that all available knowledge both clinical and non-clinical should be taken into account when making recommendations for drug usage in pregnant or lactating women, and in women of childbearing potential. This should include an integrated evaluation of non-clinical and clinical data, which includes consideration of non-clinical pharmacological and pharmacokinetic properties of the medicinal product, as well as results from non-clinical toxicity studies and of clinical experience/knowledge about compounds within the same class.
