What is Lyrica?
Lyrica (generic: pregabalin) is an anticonvulsant medication used to treat neuropathic pain (pain from damaged nerves that occurs in the hands, arms, fingers, legs, toes or feet). The drug works by reducing “extra” electrical signals sent out by damaged nerves in the body. Lyrica is made by Pfizer & Co., and was approved by the U.S. Food & Drug Administration (FDA) in June 2007.
What’s the Problem?
When taken during pregnancy, Lyrica can increase the risk of heart defects, central nervous system defects, and structural defects in organs of babies exposed to the drug in the womb. A recent study found that use of Lyrica during the first trimester tripled the risk of birth defects in exposed fetuses.
Lyrica Birth Defects
- Heart defects
- Central nervous system defects, also called neural tube defects (spina bifida, anencephaly, encephalocele)
- Structural defects in organs
Lyrica and Pregnancy
Lyrica is classified as a Pregnancy Category C medication, which means the risk in humans is unknown but animal studies have shown evidence of birth defects.
Male-Mediated Birth Defects
Men who use Lyrica should be aware that the drug has been associated with reports of male-mediated teratogenicity. Animal studies have found increased rates of skull alterations, skeletal malformations, decreased fetal body weights, and visceral variations. When offspring were tested as adults, neurobehavioral abnormalities and reproductive impairment were observed.
Lyrica Birth Defect Study
A May 2016 study published in the journal Neurology looked at the effects of Lyrica use during pregnancy. The researchers looked at data from 164 pregnant women who took Lyrica and compared them to a control group of 656 pregnant women who did not take the medication. They found that patients who used Lyrica were 3 times more likely to have babies with major birth defects than women in the control group. Specifically, 6% of pregnancies that involved the use of Lyrica resulted in defects, compared to 2% in women who didn’t take the drug.
“The significant increase in the rate of malformations observed in this study presently implies that pregabalin prescription be avoided whenever possible during pregnancy,” said Ursula Winterfeld, lead author of the study. “In patients of childbearing age, effective contraception should be advised when prescribing pregabalin, and its indication must be carefully re-examined in cases of desired or established unexpected pregnancy.”
In January 2016, Pfizer recalled 3 lots of Lyrica due to a manufacturing problem that could have left some of the capsules deformed or damaged. According to a “Dear Customer” letter issued by Pfizer, the problem could affect integrity of medication in the capsules, which means they could lose some of their active ingredients. Patients who take Lyrica affected by the recall may not be getting the full dose with each capsule.
In December 2012, Pfizer paid nearly $43 million to settle legal claims by 33 states that accused the company of illegally marketing Lyrica for “off-label” uses not approved by the FDA.
Jun 2007 – Approved by the FDA
June 21, 2007 – Lyrica first approved by the FDA.
Dec 2012 – Pfizer settles
December 2012 – Pfizer agrees to pay $43 million to settle allegations that it improperly marketed Lyrica and other medications for “off-label” uses not approved by the FDA.
January 2016 – Pfizer recalls Lyrica
January 11, 2016 – Pfizer recalls 3 lots of Lyrica over a manufacturing problem with could have left some of the capsules damaged or deformed.
May 2016 – Neurology study published
May 18, 2016 – Study published in the journal Neurology links Lyrica use during pregnancy to a three-fold increased risk for birth defects.
- “Pregnancy outcome following maternal exposure to pregabalin may call for concern”. Neurology. May 18, 2016.
- “Pfizer recalls three lots of top seller Lyrica after production issues”. FiercePharma. January 26, 2016.
- “Urgent: Drug Recall”. Pfizer. January 11, 2016.
- “Lyrica Medication Guide”. U.S. Food & Drug Administration (FDA). December 2013 (revised).
- “Pfizer Hit With $43 Million Settlement For Misleading Marketing Of Drugs”. Consumerist. December 12, 2012.
- “FDA Approves First Drug for Treating Fibromyalgia”. U.S. Food & Drug Administration (FDA). June 21, 2007.