Lyrica, the brand-name for pregabalin, was associated with a tripled risk of birth defects in a new study published in Neurology.
It is FDA-approved for epilepsy, fibromyalgia, and nerve pain. It is also prescribed “off-label” for anxiety.
To investigate the risk of birth defects, researchers looked at data on 164 women who used Lyrica during pregnancy and 656 who did not.
Of the women on Lyrica, 77% started it before they got pregnant. Nearly all of them stopped taking it six weeks into their pregnancy.
Researchers found a tripled increased risk of birth defects associated with Lyrica — 6% women on Lyrica had a baby with a major birth defect, compared to 2% of women who did not.
The birth defects associated with Lyrica include:
- Heart defects
- Central nervous system (CNS) defects
- Structural defects in organs
About 3.5% of babies exposed to Lyrica had a central nervous system defect, compared to 0.5% of non-exposed babies — more than a 6-fold increased risk. These defects include spina bifida, anencephaly, and more.
Only about 72% of women on Lyrica had a live birth, compared to 85% of women who did not take Lyrica. This was because more women on Lyrica had medically-indicated or elective abortions.
Pfizer has already paid a $43 million settlement for illegally marketing Lyrica for “off-label” uses that were not approved by the FDA. Many women take it for anxiety or migraines, which are not approved.
The study was too small to prove cause-and-effect, but researchers say women who have used Lyrica during pregnancy need extra fetal monitoring. They also say women who could get pregnant while using Lyrica should take birth control.
Source: Winterfeld U, et al. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology. 2016.