New findings on the risks of the antiepileptic agent pregabalin in pregnancy

18.05.2016 - A new international study conducted under the auspices of Lausanne University Hospital (CHUV) has shown an increased risk of birth defects following the administration of the active pharmaceutical ingredient pregabalin during pregnancy. To date Swissmedic has not received any reports of defects occurring in Switzerland after pregabalin administration. Swissmedic is now assessing whether the existing warning in the medicinal product information needs to be stronger.

"Lyrica should not be used during pregnancy unless prescribed by your doctor. Women of childbearing age must use effective contraception." This warning already appears in the Patient Information. In the light of the results of a new study, Swissmedic is now assessing whether this warning needs to be stronger.

Pregabalin is a prescription-only medicine that is used to treat epilepsy and, more frequently, neuropathic pain. It is also authorised for the treatment of certain anxiety disorders. The medicinal products containing this active pharmaceutical ingredient that are authorised in Switzerland are Lyrica®, Pregabalin-Mepha, Pregabalin Pfizer® and Pregabalin Sandoz®.

The Swiss Teratogen Information Service (STIS) at Lausanne University Hospital (CHUV) has coordinated a study that is investigating the risk of birth defects (teratogenic effects) following the administration of pregabalin in pregnancy. STIS is the Swiss information and documentation agency for drug risks in pregnancy and works with Swissmedic.

The multicentre study investigated data from eight member centres of ENTIS (European Network of Teratology Information Services) concerning 164 women who took pregabalin during pregnancy. In particular, the course and development of their pregnancies and the condition of their children after birth were investigated. The results were compared with data for a control group of 656 women who did not use any of these problematic medicinal products during their pregnancy. In the children of women who took pregabalin during pregnancy, the risk of defects was three times higher (6 percent compared to 2.1 percent in the control group). Swissmedic has not received any reports of defects occurring in Switzerland after pregabalin administration.

The scientists stress that by virtue of the limitations of the study, this only represents an initial safety signal. While conceding that the sample size was limited, they emphasised that there were fewer illnesses in control group than among the women who had received pregabalin. Illnesses during pregnancy can affect the risk of birth defects. The women in the control group were also taking fewer medicinal products overall. Consequently, the authors believe that further studies are needed to clarify the risk. Nevertheless, in view of the results, they recommend that pregabalin should be avoided as far as possible during pregnancy.