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Epilepsy Newfoundland and Labrador
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| Drug Alert Notices | |
Phenobarbital in Pregnancy Increases Birth Defect Risk
Findings from the North American Antiepileptic Drug (AED) Pregnancy Registry confirm that prenatal exposure to the anticonvulsant drug phenobarbital significantly increases the risk of fetal abnormalities.
"Phenobarbital had been on the market since 1912 and many doctors assumed it was safe," Dr. Lewis B. Holmes from the Genetics & Teratology Unit at Massachusetts General Hospital told Reuters Health. "Within the past 10 years several studies suggested that exposure to phenobarbital posed a serious risk. The AED Pregnancy Registry...confirmed this high risk."
Among 3002 pregnant women enrolled in the registry between 1997 and 2002, seventy-seven were exposed to phenobarbital and 5 (6.5 percent) of these 77 women delivered an infant with a major malformation, investigators report in the Archives of Neurology.
When compared with the rate in the general population of 1.62 percent, there was a greater than four-fold increased risk of major malformations in offspring exposed in to phenobarbital in the uterus, they note.
There is "equal concern" that prenatal phenobarbital exposure may adversely affect intelligence, Holmes noted. "Other studies are underway--not at the Registry--to address this possibility," he said.
SOURCE: Archives of Neurology, May 2004.
By Megan Rauscher, Reuters Health, May 21, 2004
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People with epilepsy should never discontinue anti-epileptic medications or make changes in activities unless specifically advised to do so by an attending physician.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use this medication only for the condition prescribed.
