The commonly prescribed medicine, pregabalin (marketed in Australia as Lyrica), has been linked to major birth defects, a new study reveals.

Women who take the drug in the first trimester of pregnancy are 3 times more likely to have a baby with malformations than those not on the medication.

Heart defects and structural problems with the central nervous system (CNS) or other organs are the most common adverse fetal effects associated with the drug which is primarily used to treat neuropathic pain, fibromyalgia and epilepsy.

The findings highlight the need for caution when women of childbearing age are taking pregabalin.

The study of 164 women who took pregabalin during pregnancy and 656 pregnant women who were not taking any anticonvulsant medication, found women on pregabalin were 6 times more likely to have a pregnancy with a major defect in the central nervous system.

The literature also shows relatively low levels of exposure to the drug may be enough to cause fetal malformations. In this study pregabalin was discontinued at around 6 weeks suggesting many of these pregnancies were unplanned.

However, the Swiss researchers say they can’t draw any definitive conclusions from their work as most of the women on pregabalin were also taking other medications at the time.

‘The study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” says lead author Dr Ursula Winterfeld, from Lausanne University Hospital.

A spokesperson from Pfizer, which markets pregabalin under the brand name, Lyrica, says it should also be noted that the women taking the drug also had higher rates of smoking and diabetes “all of which negatively affect pregnancy outcomes”.

Here is the Australian Consumer Medicine Information for Lyrica.

The local Australian product information states: Lyrica has not been studied in pregnant women and Lyrica should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus.

19 May 2016

Last Reviewed: 19/05/2016

Reproduced with kind permission from


Pregnancy outcome following maternal exposure to pregabalin may call for concern