tcf-no-longer-accepting-casesThe anti-seizure drug Lyrica has been linked to a tripled increased risk of major birth defects, especially heart defects and neural tube defects like spina bifida.

What is the problem?

Lyrica is an epilepsy drug that treats chronic pain. When it is taken during pregnancy, studies suggest it increases the risk of certain birth defects, including heart defects, organ defects, and neural defects.

Lyrica and Male-Mediated Birth Defects

Lyrica may carry a risk of male-mediated birth defects, in which the mother has a child with a birth defect when the father was on Lyrica.

Animal studies have shown that Lyrica made males less fertile and caused sperm to change. Also, animal studies showed that birth defects occurred in offspring of male animals on Lyrica. It is unknown if these risks apply to humans.

Study Links Lyrica and Birth Defects

A study published in Neurology investigated Lyrica in 164 pregnant women in 7 countries.

Women who took Lyrica in the first trimester were 3-times more likely to have a baby with a “major birth defect” compared to 656 pregnant women who did not take Lyrica or other anti-seizure drugs.

Major birth defects occurred in 6% of pregnancies exposed to Lyrica, compared to 2% of non-exposed pregnancies.

Lyrica was also associated with a 6-fold increase risk of Central Nervous System (CNS) birth defects — 3.2% vs. 0.5% for non-exposed pregnancies.

However, the authors of the study said it was too small to conclude that Lyrica causes birth defects.

The observational study (PDF), “Pregnancy outcome following maternal exposure to pregabalin may call for concern,” was published online in Neurology, the medical journal of the American Academy of Neurology (AAN).

What are CNS Defects?

CNS defects are also known as neural tube defects, and they include spina bifida, anencephaly, and encephalocele. These birth defects occur during the first few weeks of pregnancy when the spinal column does not close completely. This can cause nerve damage, paralysis, or under-development of the brain and skull.

Lyrica and Heart Defects

Lyrica was also associated with heart defects and structural problems with other organs. These defects can involve the walls of the heart, valves, and arteries and veins near the heart. Symptoms in newborns may include:

  • Rapid breathing
  • Cyanosis – a bluish tint to the skin, lips, and fingernails
  • Fatigue
  • Poor blood circulation

Lyrica Pregnancy Category C

Lyrica contains pregabalin, a “Pregnancy Category C” drug, which means studies in animals have found evidence of birth defects, but the risk in humans is unknown. Pfizer warns that women should not take Lyrica and breast-feed a baby.


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