Maternal Exposure to Pregabalin May Cause Birth Defects

First-trimester exposure to pregabalin may increase the risk of major birth defects, according to a study published online ahead of print May 18 in Neurology.

Pregabalin is an FDA-approved treatment for seizures and neuropathic pain. It is also a common off-label treatment for restless legs syndrome, cyclic mood disorders, and generalized anxiety disorder.

Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and colleagues conducted a multicenter, observational cohort study in which they compared pregnancy outcomes of 164 women exposed to pregabalin with 656 controls who were not exposed to any known teratogenic medications or antiepileptic drugs. Data for this study were collected from 2004 to 2013 and included data from France, the United Kingdom, Italy, Finland, Switzerland, the Netherlands, and Turkey.

Of the women on the medication, 77% started taking pregabalin before they became pregnant and stopped taking the drug at a median of six weeks into their pregnancies. Of the women taking pregabalin, 13% were also taking another antiepileptic drug.

Pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of women who did not take the drug—6.0% versus 2.1%, respectively. The major birth defects included heart defects and structural problems with the CNS or other organ systems. The study also revealed a lower rate of live births in the pregabalin group due to elective and medically indicated pregnancy terminations.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because 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,” said Dr. Winterfeld.

She suggested that before a woman is prescribed pregabalin, it is important to make sure the benefits outweigh the risks and that she is carefully informed about the use of effective birth control.

—Adaeze Stephanie Onyechi

First-trimester exposure to pregabalin may increase the risk of major birth defects, according to a study published online ahead of print May 18 in Neurology.

Pregabalin is an FDA-approved treatment for seizures and neuropathic pain. It is also a common off-label treatment for restless legs syndrome, cyclic mood disorders, and generalized anxiety disorder.

Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and colleagues conducted a multicenter, observational cohort study in which they compared pregnancy outcomes of 164 women exposed to pregabalin with 656 controls who were not exposed to any known teratogenic medications or antiepileptic drugs. Data for this study were collected from 2004 to 2013 and included data from France, the United Kingdom, Italy, Finland, Switzerland, the Netherlands, and Turkey.

Of the women on the medication, 77% started taking pregabalin before they became pregnant and stopped taking the drug at a median of six weeks into their pregnancies. Of the women taking pregabalin, 13% were also taking another antiepileptic drug.

Pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of women who did not take the drug—6.0% versus 2.1%, respectively. The major birth defects included heart defects and structural problems with the CNS or other organ systems. The study also revealed a lower rate of live births in the pregabalin group due to elective and medically indicated pregnancy terminations.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because 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,” said Dr. Winterfeld.

She suggested that before a woman is prescribed pregabalin, it is important to make sure the benefits outweigh the risks and that she is carefully informed about the use of effective birth control.

—Adaeze Stephanie Onyechi

First-trimester exposure to pregabalin may increase the risk of major birth defects, according to a study published online ahead of print May 18 in Neurology.

Pregabalin is an FDA-approved treatment for seizures and neuropathic pain. It is also a common off-label treatment for restless legs syndrome, cyclic mood disorders, and generalized anxiety disorder.

Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and colleagues conducted a multicenter, observational cohort study in which they compared pregnancy outcomes of 164 women exposed to pregabalin with 656 controls who were not exposed to any known teratogenic medications or antiepileptic drugs. Data for this study were collected from 2004 to 2013 and included data from France, the United Kingdom, Italy, Finland, Switzerland, the Netherlands, and Turkey.

Of the women on the medication, 77% started taking pregabalin before they became pregnant and stopped taking the drug at a median of six weeks into their pregnancies. Of the women taking pregabalin, 13% were also taking another antiepileptic drug.

Pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of women who did not take the drug—6.0% versus 2.1%, respectively. The major birth defects included heart defects and structural problems with the CNS or other organ systems. The study also revealed a lower rate of live births in the pregabalin group due to elective and medically indicated pregnancy terminations.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because 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,” said Dr. Winterfeld.

She suggested that before a woman is prescribed pregabalin, it is important to make sure the benefits outweigh the risks and that she is carefully informed about the use of effective birth control.

—Adaeze Stephanie Onyechi