Antiseizure Drug Depakote Under Fire
Evidence Linking Depakote to Birth Defects Is Mounting
Getting the Answers continued...
Studies do suggest that the risk of birth defects and mental problems among babies born to women taking Lamictal is no greater than among the general population of pregnant women. Lamictal manufacturer GlaxoSmithKline sponsored Tuesday's news briefing. GlaxoSmithKline is a WebMD sponsor.
The news conference was held, in part, to urge pregnant women on antiseizure drugs to participate in a national registry designed to clarify the risks and benefits of the medications. So far, 4,000 women taking 21 different medications have enrolled in the North American Antiepileptic Drug Pregnancy Registry, but conference organizers said much larger numbers are needed to get the answers they need.
The toll free number for the registry is (888) 233-2334, and the hotline is available in both Spanish and English-language versions.
Neurologist Martha J. Morrell, MD, has been treating women with epilepsy for 18 years. She said Tuesday that for years she had no answer when her pregnant patients asked if the drugs they were taking would harm their babies.
"So much of our decision making has been based on poor data and on our own experiences," she said. "This is the first time that we have had real information to give our patients, and the information on [Depakote] is extremely concerning."
Most Babies Are OK
Neurologist Gregory L. Barkley, MD, of Wayne State University, emphasized that most women taking antiseizure drugs during pregnancy give birth to normal children. And he added that for many women the benefits of treatment clearly outweigh the risks.
"We don't want women to abruptly stop taking these drugs," he said.
Morrell said while Depakote may be the only appropriate treatment for some women, many others who are taking it for epilepsy, bipolar disorder, or migraine headaches may do just as well on another medication.
"Any woman taking [Depakote who might become pregnant] should talk to her physician about whether it is appropriate to continue," she said.