Neurology Central

Pregabalin potentially linked to increased risks of birth defects

Pregabalin, commonly utilized in the treatment of pain, epilepsy and some other neurological disorders, has been linked with an increased risk of birth defects in a new study published in Neurology.

The recent study was carried out by researchers at the University of Lausanne (Switzerland), who collected data from 164 women from seven different countries who had taken pregabalin during pregnancy. They also compiled data from 656 women who had not taken pregabalin during pregnancy.

Reasons for the prescription of pregabalin for the study participants varied from neuropathic pain (115 individuals), psychiatric disorders (39 individuals), epilepsy (five individuals) and restless leg syndrome (one individual).

Within the cohort, pregabalin was taken prior to pregnancy in 77% of the women and on average administration of the drug was discontinued 6 weeks into the term. A total of 22% were also taking at least one other anti-seizure drug.

Follow-ups were carried out by contacting the women directly or their practitioners following the expected delivery date. Results indicated that within women who took pregabalin during the first trimester of pregnancy, the likelihood of children being born with major defects was three times higher than for women who did not take the drug. In total, 6% of pregnancies in women taking pregabalin resulted in major birth defects in comparison to 2% in the non-pregabalin group.

Birth defects observed included heart defects and structural problems with the central nervous system and other organs – defects as a result of chromosomal abnormalities were discounted from the final results. Women prescribed pregabalin also indicated a 6x increased risk of CNS defects alone.

The research team urges that definitive conclusions cannot yet be drawn from the study’s results due to its relatively small size and the fact that many of the women were also taking additional drugs that could have impacted birth outcomes, however the findings do indicate a potential risk of birth defects that should be investigated further.

Study author, Ursula Winterfeld (University of Lausanne) commented: “Pregabalin should be prescribed for women of child-bearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted.”

Source: American Academy of Neurology press release