Pregabalin and risks in pregnancy

AI Summary

In April 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued updated safety guidance regarding the medication pregabalin, commonly known by brand names Lyrica, Alzain, Axalid, and Lecaent. This notification follows a comprehensive review of a European study which identified a slight increase in the risk of physical birth abnormalities when pregabalin is used during early pregnancy. The study found that approximately 6 in 100 babies exposed to the drug in the first trimester were born with abnormalities, compared to 4 in 100 in the untreated population. This risk appears higher than that associated with alternative treatments such as lamotrigine or duloxetine. Under the MHRA's safety framework, individuals capable of becoming pregnant must continue using effective contraception while on this treatment. The guidance requires patients to consult with their healthcare providers before planning a pregnancy or if they suspect they are pregnant. Crucially, the MHRA warns against the abrupt cessation of pregabalin without medical supervision, as doing so—particularly for epilepsy patients—may cause a dangerous increase in seizures. Required actions include establishing a joint treatment plan with a doctor to weigh the risks of the medication against the risks of untreated conditions like anxiety or nerve pain. Furthermore, all suspected side effects must be reported through the MHRA Yellow Card scheme. This safety advice was scheduled for further review in October 2022.