Animal Studies Have Lyrica Possibly Linked To Skeletal Malformations, Neural Tube Defects, And Other Abnormalities, But Safety Data On Lyrica Use During Human Pregnancy Are Scarce
Women who took Lyrica (pregabalin) while pregnant were about three times more likely to have babies with major birth defects compared with women who did not take Lyrica, according to study done by a team of medical researchers in Europe that was recently reported in the journal Neurology.
From the Abstract for this report, "Pregnancy outcome following maternal exposure to pregabalin may call for concern", from the Neurology.org website ("Published online before print May 18, 2016") we get an overview of the new Lyrica research:
Objective: To investigate pregnancy outcomes following maternal use of [Lyrica (pregabalin)].
Methods: This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to [Lyrica (pregabalin)] with those of matched controls (not exposed to any medications known to be teratogenic or to any antiepileptic drugs)....
Conclusions: This study demonstrated a signal for increased risk of major birth defects after first trimester exposure to [Lyrica (pregabalin)]. However, several limitations such as the small sample size, differences across groups in maternal conditions, and concomitant medication exposure exclude definitive conclusions, so these results call for confirmation through independent studies.
This May 19, 2016 article, "Pregabalin Exposure During First Trimester of Pregnancy May Raise Risk of Major Birth Defects" published by Neurology Today provided some details from the medical journal report about Lyrica and birth defects:
Pregnant women who took [Lyrica (pregabalin)] in one multicenter, prospective study had infants with a higher rate of major birth defects than a group of matched control subjects not taking an antiepileptic medication, according to a study published in the May 18 online edition of Neurology.Most of the women — 96 percent — were exposed to [Lyrica (pregabalin)] during their first trimester of pregnancy, and were taking it for relief of pain (73 percent for migraine and neuropathic pain), psychiatric disorders (45.1 percent, with some overlap with pain disorders), and epilepsy (3 percent).While animal studies have suggested reproductive toxicity for [Lyrica (pregabalin)] with skeletal malformations, neural tube defects, and other abnormalities, data on [Lyrica (pregabalin)] use during human pregnancy are scarce, the study authors noted....
Examining medication exposure during the first trimester of pregnancy separately and excluding chromosomal aberration syndromes, researchers found a significantly higher rate of major birth defects in women taking [Lyrica (pregabalin)] during pregnancy than those in the control group — seven out of 116 or 6 percent compared with 12 out of 580 or 2.1 percent; OR 3.0, 95 percent CI (1.2-7.9, p=0.03).When researchers limited analysis to 19 patients who took [Lyrica (pregabalin)] monotherapy during the first trimester of pregnancy and compared them to the control group, the association with major birth defects remained significant — three out of 19 or 15.8 percent compared with 16 of 573 or 2.8 percent; OR 6.5, 95 percent CI 1.7-24.7, p=0.02 — but became non-significant after exclusion of chromosomal or genetic anomalies.
The birth defects in the [Lyrica (pregabalin)] group included one infant also exposed to another antiepileptic medication who developed with multiple cardiac defects. The study authors noted that in this case, [Lyrica (pregabalin)] exposure occurred beyond the critical period for cardiac birth defects, however. Other major birth defects in the [Lyrica (pregabalin)]-exposed group included four chromosomal and eight structural anomalies distributed in the central nervous system (n=4), skeletal system (n=2), heart (n=2), and skin or vascular system (n=1).
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From a May 19, 2016 Medpage Today article, "Human Birth Defects Seen With Pregabalin -- Time for a pregnancy category change?", we get this contextual information and commentary about this recent Lyrica - birth defects medical study:
The FDA currently classifies [Lyrica (pregabalin)] as pregnancy category C, indicating that teratogenic effects have been seen in animal studies but there are "no adequate and well controlled studies in pregnant women." Whether the agency will revise [Lyrica (pregabalin)]'s label on the basis of the new study remains to be seen.
Max Wiznitzer, MD, of UH Rainbow Babies and Children's Hospital in Cleveland, who was not involved in the study, said it raises important questions, but is "not definitive proof" that [Lyrica (pregabalin)] causes these birth defects because the study was small, doesn't hone in on a single defect or syndrome and included many mothers-to-be who were also taking other medications. He said it warranted further research.
We will continue to monitor the medical literature for any more research done on this drug safety issue of pregnant women using Lyrica having an increased risk of having children with birth defects. We will also watch to see whether the FDA decides there should be any Lyrica label change, such as changing the pregnancy category for Lyrica.