Lyrica is commonly prescribed to prevent seizures and treat mental illness, but a new study has found that it triples the risk of major birth defects when it is taken during the first three months of pregnancy.
What is Lyrica?
Lyrica is the brand-name for a prescription medicine called pregabalin, made by Pfizer and approved in 2004. Lyrica is approved to treat nerve pain, fibromyalgia, and prevent seizures due to epilepsy.
Pfizer Pays $43 Million Lyrica Settlement
Lyrica is commonly prescribed “off-label” for women with anxiety and other mental illnesses that are not approved by the FDA. In December 2012, Pfizer agreed to pay a $42.9 million settlement with 33 states who said Pfizer illegally marketed Lyrica for unapproved uses like chronic pain and migraines.
Lyrica and Birth Defects
In May 2016, a study published in Neurology has found an increased risk of birth defects after exposure to Lyrica, including:
- Heart defects
- Central nervous system defects
- Structural defects in organs
These defects start in the first few weeks of fetal development, before most women are aware of pregnancy.
Researchers looked at outcomes for 164 pregnant women who took Lyrica during the first trimester compared to 656 women who did not. Nearly all of the women stopped taking Lyrica six weeks into their pregnancy. The women were contacted again after their delivery date.
Overall, babies exposed to Lyrica were three times more likely to have a major birth defect — 6% vs. 2%. Women taken Lyrica were 6-times more likely to have a baby with a major defect in the central nervous system (3.2% vs. 0.5%).
Only about 72% of pregnant women who used Lyrica had a live birth, compared to 85% in the control group. The difference was blamed on a higher rate of medically-indicated and elective abortions among women on Lyrica.
Source: Winterfeld U, Merlob P, Baud D, et al. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology 2016.
Recommendation for Patients
The study was small and it does not prove that Lyrica causes birth defects. Even so, experts say pregnant women should probably avoid Lyrica. The authors of the study recommended that all women of childbearing age on Lyrica should take birth control. Women who have already taken Lyrica during pregnancy may need extra fetal monitoring, according to the authors of the study.