Small Study Suggests Elevated Risk for Major Birth Defects

Conclusions from a recent study suggest that pregabalin, approved by the FDA for the treatment of fibromyalgia and neuropathic pain, as well as other conditions, may be associated with an elevated risk for major birth defects. These include heart defects, structural issues with other organs, and central nervous system damage. The study found that women who took pregabalin during the first trimester of pregnancy were 3 times as likely to deliver babies with defects of these categories. Birth defects due to chromosomal abnormality were excluded from the reported results. The research was published online last week in the journal Neurology®.

The study examined records of 164 women from 7 countries who took pregabalin during a pregnancy and 656 pregnant women who did not take any anti-seizure medication. Some of the study subjects who took pregabalin were also taking other anti-seizure drugs as well. Study author Ursula Winterfeld, PhD, with the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland commented “We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects.” She also pointed out the small sample size represented and the need for further confirmation. Nonetheless, Winterfeld noted, the possibility of association suggests that caution is warranted in prescribing pregabalin for women of childbearing age. Read a news story about the research conclusions here. The journal abstract may be read here.


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