May 19, 2016
Pregabalin Usage Throughout Pregnancy Tied to Birth Defects
A small observational study of very first trimester maternal exposure to pregabalin discovered a potential increased risk for serious birth defects.
The drug, used to handle neuropathic pain and partial-onset seizures, is regularly used off-label in women, according to a previous Swedish study. Despite the fact that there is limited data for the Usage of pregabalin in pregnancy, pet studies have actually linked its Usage to reproductive toxicity. Along with several pregnancies unplanned, the risk of exposure to the creating fetus is high.
Ursula Winterfeld, PhD, of the Division of Pharmacology at the Centre Hospitalier in Lusanne, Switzerland and colleagues conducted a multicenter, observational prospective cohort study to compare outcomes in pregnant women exposed to pregabalin and matched controls. The data was obtained from the Teratology Short article Solutions of 8 European countries from 2004 to 2013. The study included 164 patients Along with maternal exposure to pregabalin and 65six matched controls. Treatment indications included restless leg syndrome (n=1), epilepsy (n=5), psychiatric disorders (n=39), and neuropathic ache (n=115).
The median pregabalin dose was 150 mg everyday and was initiated prior to pregnancy in 77% of patients. Pregabalin was discontinued at a median gestational age of six weeks. However, 61% of patients continued pregabalin after six weeks and 33% continued after 7 weeks of gestation. A lot of exposures were Throughout the very first trimester (96%). Concomitant treatment Along with one more antiepileptic drug was observed in 13% of patients.
Overall, serious birth defects were observed much more regularly in the pregabalin group (9.6% vs 2.8%, OR 3.7, 95% CI: 1.5-8.6, P<.001). Once cases Along with chromosomal syndromes were excluded and limited to very first trimester exposure, the price of serious birth defects remained greater in the pregabalin group (6% vs 2.1%, OR 3.0, 95% CI: 1.2-7.9, P=.03). The pregabalin group additionally had a reduced price of live births compared to the manage group (71.9% vs 85.2%, P<.001). This difference was mostly attributed to a greater price of medically-indicated and elective terminations. Exposure was not significantly associated Along with a greater risk of spontaneous abortion in Cox proportional analysis (HR 1.60, 95% CI: 0.95-2.71, P=.08).
“In our opinion, the considerable improve in the price of serious malformations observed in this study need to currently imply that pregabalin prescription be avoided whenever feasible Throughout pregnancy,” Dr Winterfeld and co-author Theirry Buclin, MD, told Neurology Advisor. “In patients of childbearing age, efficient contraception need to be advised Once prescribing pregabalin, and its indication need to be carefully re-examined in cases of desired or established pregnancy.”
Still, the authors recognized that the outcomes are limited and “should be confirmed by further independent studies prior to pregabalin deserves to be position Along with certainty among malformation-inducing drugs,” they said.
In an accompanying editorial, Page Pennell, MD, of Harvard Medical School and Kimford J. Meador, MD, of Stanford University School of Medicine, noted that the study was limited by a small sample size and the differences between the study and manage groups, including medical conditions, medication use, tobacco use, and gestational age at contact. The outcomes “offer a signal of concern that MCMs are greater in pregnancies of women on pregabalin Along with a lot of various other factors compared to a manage population,” they wrote.
Further research is called for to confirm the findings, the authors said, and patients need to be counseled on the potential risks and rewards of neuropsychiatric medications prior to pregnancy.
References
- Winterfeld U, Merlob P, Baud D, et al. Pregnancy outcome complying with maternal exposure to pregabalin Could call for concern. Neurology 2016; doi:10.1212/WNL.0000000000002767.
- Pennell PB and Meador KJ. A common medication for neuropsychiatric illnesses Could induce common complications in pregnancy. Neurology 2016; doi:10.1212/WNL.0000000000002780.
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