Comments on “Headache: pregnancy and breastfeeding. Recommendations of the Spanish Society of Neurology's Headache Study Group”

Dear Editor:

We would like to comment on 2 relevant aspects of the article “Headache: pregnancy and breastfeeding. Recommendations of the Spanish Society of Neurology's Headache Study Group,” published online in April 2019.¹ Firstly, we wish to mention the notice issued by the Spanish Agency for Medicines and Medical Devices on 12 September 2019,² which warned about a slight increase in the risk of orofacial clefts in children of women exposed to ondansetron during the first trimester of pregnancy. This drug should therefore be avoided in pregnant women, especially during the first trimester; pregnant women should be informed about these potential adverse effects, and effective contraceptive measures should be implemented when necessary.³

We would also like to stress the fact that no drug is exempt from risks, particularly in this population group; we should therefore be cautious and aim to avoid pharmacological treatment in these patients whenever possible. If pharmacological treatment is unavoidable, drugs should be selected in order of their safety, according to the safety data available, and patients must be duly informed about the associated risks. Lastly, any suspected adverse reaction must be reported through the appropriate pharmacovigilance systems.