A new study has found that pregnant women who take the epilepsy drug Lyrica could be 3X more likely to have a baby with a major birth defect, including heart defects and nervous system defects like spina bifida.
Lyrica is an anti-convulsant drug that prevents epileptic seizures and treats nerve pain (neuropathy) and fibromyalgia. It is also widely used “off-label” for anxiety. When Lyrica is taken during pregnancy, studies suggest it increases the risk of birth defects, heart defects, organ damage, and neural defects like spina bifida.
Lyrica and Male-Mediated Birth Defects
Male-mediated birth defects are possible when the father takes Lyrica. In animal studies, Lyrica made males less fertile and caused changes in sperm. These studies also showed birth defects in offspring of male animals on Lyrica, though it is unknown if the risk applies to people.
Study Links Lyrica and Birth Defects
In May 2016, Neurology published a study investigating 164 pregnant women in 7 countries who used Lyrica.
Major birth defects were 3-times more common in babies exposed to Lyrica, compared to 656 pregnant women who did not use Lyrica — 6% of exposed babies had a “major birth defect” compared to 2% of non-exposed babies.
The study also found a 6-fold increased risk of Central Nervous System (CNS) defects, which occurred in 3.2% of Lyrica-exposed babies compared to 0.5% of non-exposed babies.
The study was too small to conclude that Lyrica causes birth defects, but it is concerning. The researchers recommended against using Lyrica during pregnancy.
The study was published online in Neurology, the medical journal of the American Academy of Neurology (AAN) — “Pregnancy outcome following maternal exposure to pregabalin may call for concern.”
What are CNS Birth Defects?
CNS defects are more commonly called neural tube defects, and include defects like spina bifida, anencephaly, and encephalocele. They occur in very early in fetal development when the spinal column does not close, allowing amniotic fluid to damage the spinal cord. It often causes nerve damage, paralysis, and under-development of the brain and skull.
Lyrica and Heart Defects
Babies exposed to Lyrica may develop heart defects and other structural problems with vital organs. In newborns, heart defects can cause the following symptoms:
- Rapid breathing
- Cyanosis (“blue baby”) – bluish tint to skin, nails, lips
- Weakness and fatigue
- Poor circulation
- Failure to thrive
What Pregnancy Category is Lyrica?
Lyrica is a “Pregnancy Category C” drug, which means it is associated with birth defects in animal studies but the risk in people is unknown. The manufacturer warns against using Lyrica if you are breast-feeding because it could pass into breast milk.