A commonly prescribed medication to treat epilepsy and pain may be linked to an increased risk of birth defects when taken during pregnancy, a new study suggests.
The drug pregabalin (Lyrica) was permitted by the Food and Drug Administration (FDA) to treat fibromyalgia, epilepsy, and neuropathic pain, including pain after an injury in the spinal cord or pain from diabetic neuropathy.
Pregabalin is also used in off-label prescribing, in which doctors recommend it to patients with generalized anxiety disorder and other mental health conditions. The process is common and legal.
Pregabalin And Its Possible Side-Effects
In a small-scale study, experts from Switzerland gathered information in seven countries from 164 women who took pregabalin during pregnancy, and 656 women who were not taking seizure drugs.
The participants and their general practitioners were contacted again after their date of delivery.
Researchers discovered the following:
• Approximately 115 pregnant women who took pregabalin used it to treat neuropathic pain; 39 took it for psychiatric disorders such as anxiety, depression, psychosis, and bipolar disorder; five took it for epilepsy; and one took it to treat restless leg syndrome.
• About 77 percent of these women took pregabalin before they were pregnant. They stopped taking the drug six weeks into their pregnancies.
• About 6 percent or seven of the 116 women taking pregabalin during their first trimester of pregnancy had infants who were born with major birth defects.
• About 2 percent or 12 out of 580 women who were not taking the drug had infants with major birth defects.
• The babies were struck with birth defects that included heart defects and structural problems with their central nervous system.
• Those who took pregabalin were six times more likely to have a pregnancy with a major birth defect that affected the central nervous system.
Limitations Of The Study
There is a caveat, however: the findings of the study are not conclusive because they do not draw a cause-and-effect relationship.
What's more, the study does not take into account other medical conditions or medications that could have affected pregnancy outcomes, including rates of diabetes or smoking.
Dr. Thierry Buclin, senior author of the study, said the results of the study should be taken with caution.
"It's a warning, but it cannot be taken as a certainty," said Buclin.
Although animal studies have also linked Lyrica to birth defects, Buclin said there were many cases of drugs showing negative effects on animals but being relatively safe in humans.
However, Buclin does not recommend Lyrica for those who want to become pregnant.
Dr. Page Pennell of Harvard Medical School agrees.
"The risk of birth defects is probably higher with Lyrica," said Pennell.
She said it is important to plan pregnancies especially when you are taking anti-seizure drugs. A planned pregnancy would allow women to discuss their options with doctors, she added.
The findings of the study are published in the journal Neurology.
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