Procyclidine is an anticholinergic agent used mainly for the treatment of idiopathic or drug-induced dystonic reactions and Parkinson’s disease.
There are no published data regarding the fetal effects of procyclidine use in human pregnancy. UKTIS have collected over 60 prospective pregnancy outcomes. Although these data do not suggest that procyclidine use in pregnancy is associated with increased risks of adverse fetal outcomes, the small sample size and maternal co-exposure to other medications limits the conclusions that can currently be provided.
Where maternal treatment with procyclidine is clinically indicated, patients should be carefully counselled about the limited safety data currently available. Use in pregnancy should be reserved for cases where the benefits of maternal treatment are expected to outweigh the inadequately determined fetal risks.
Drug-induced dystonic reactions are commonly associated with antipsychotic use. An increased incidence of neonatal complications has been reported in the offspring of patients with psychotic illnesses; however the relative contributions of the underlying maternal condition and specific drug treatments have not been clearly defined. Use of centrally acting drugs throughout pregnancy or around the time of delivery is associated with an increased risk of poor neonatal adaptation syndrome (PNAS). Maternal exposure to procyclidine prior to delivery may also result in anticholinergic side effects such as urinary retention, constipation, increased heart rate and neurological disturbance in the newborn. Monitoring of the neonate post-delivery is advised.
Given the lack of pregnancy safety data, a detailed fetal anomaly scan is recommended where exposure to procyclidine has occurred in the first trimester of pregnancy. 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 considering the need for additional pregnancy monitoring. Discussion with UKTIS is recommended in all cases.
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.