Posted by Phillipa on November 3, 2009, at 19:20:57
Seems this is not the med of choice for women who may become pregnant. Phillipa
AES 2008: Valproate Should Not Be Used in Women Who May Become Pregnant: NEAD Study CME
News Author: Allison Gandey
CME Author: Laurie Barclay, MD
CME Information
Target Audience
This article is intended for clinicians who want to maintain a current understanding of recent research and evidence regarding the use of valproate in women with epilepsy who may become pregnant.Goal
The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.Authors and Disclosures
Allison Gandey
Allison Gandey is a senior journalist for Medscape Neurology & Neurosurgery. Allison was part of theheart.org and jointandbone.org news teams, which were acquired by WebMD. She is the former science affairs analyst for the Canadian Medical Association Journal. Allison is a guest speaker at the Carleton University School of Journalism and Communication. Working with the national science reporter at the Toronto Star and an associate professor at Carleton University, Allison developed guidelines for journalists covering medical news. She has a master of journalism specializing in science reporting and a commerce diploma. Allison has edited a variety of medical association publications and has done some work in radio and television. She can be contacted at agandey@medscape.net.
Disclosure: Allison Gandey has disclosed no relevant financial relationships.Brande Nicole Martin
Brande Nicole Martin is the News CME editor for Medscape Medical News.
Disclosure: Brande Nicole Martin has disclosed no relevant financial information.Laurie Barclay, MD
is a freelance reviewer and writer for Medscape.
Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.Learning Objectives
Upon completion of this activity, participants will be able to:1.Inform clinicians of the latest medical information about the association of valproate use during pregnancy with the risk for major congenital abnormalities and fetal death, as presented at the American Epilepsy Society 62nd Annual Meeting.
2.Describe the relevance of the findings that valproate use during pregnancy was associated with impaired cognitive development in the offspring vs other commonly used antiepileptic drugs to clinicians in the care of women with epilepsy who may become pregnant.
From the AES 2008: American Epilepsy Society 62nd Annual MeetingDecember 11, 2008 (Seattle, Washington) Valproate should not be used as first-line treatment of epilepsy in women of childbearing potential because it poses a greater risk to neurodevelopmental outcomes in infants vs alternative antiepileptic drugs, report investigators.
Dr. Kimford Meador presenting the results at an evening platform session.Their conclusion is based on 3-year cognitive outcome results from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. The findings were presented here at the AES 2008: American Epilepsy Society 62nd Annual Meeting.
"If I choose the wrong antiepileptic drug, I can always go back and fix that," lead investigator Kimford Meador, MD, from the University of Florida in Gainesville said at the meeting. "But if I prescribe valproate and things go wrong because of its teratogenicity, I can't do anything about that."
During an interview, both session moderators said they agree, and clinicians should err on the side of caution when it comes to treating female patients of childbearing age.
"This is an important study and it is going to change the way we practice," said Paul Van Ness, MD, from Southwestern Medical Center in Dallas, Texas. "Valproate is a great drug. It works and it's inexpensive, but we now know there are other potentially safer options for women who may become pregnant."
Comoderator Marlis Frey, APN, from Rush Medical College in Chicago, Illinois, echoed Dr. Van Ness' comments and added that the majority of pregnancies are not planned, so diligence could prove important even for women who do not intend to have children.
The popular epilepsy medication is also used for other indications such as bipolar disorder and migraine.
Another study published last week in Neurology suggested a link between valproate during pregnancy and autism spectrum disorders in children (Neurology. 2008;71:1923-1924).
However, the NEAD results are the most convincing to date describing the neurodevelopmental consequences of fetal exposure, say the session moderators.
Safer Options
NEAD is an ongoing prospective observational multicenter study in the United States and the United Kingdom. The purpose of the work is to determine the long-term neurodevelopmental effects of 4 commonly used antiepileptic drugs: carbamazepine, lamotrigine, phenytoin, and valproate.
Investigators are reporting the cognitive outcomes in more than 250 children aged 3 years. The ultimate goal of NEAD is to observe the children to age 6 years. The first results were published in 2006 and were reported at the time by Medscape Neurology & Neurosurgery. Dr. Meador and his team showed that valproate was associated with a significant risk for major congenital abnormalities and fetal death.
These new cognitive-outcome results suggest additional cause for concern. Dr. Meador and his team found that children exposed to valproate in utero had significantly lower IQs vs those who had been exposed to other antiepileptic drugs. The researchers adjusted mean IQs for maternal IQ, age, drug dose, gestational age, and folate.
Table. Mean IQ After Fetal Exposure to Antiepileptic Drugs
Drug Mean IQ 95% Confidence Interval P Value
Valproate 89
Carbamazepine 98 2.8 - 5.4 .009
Lamotrigine 102 6.4 - 18.6 .003
Phenytoin 97 0.2 - 15.5 .04
"In utero exposure to valproate is more likely to impair cognitive development than other commonly used antiepileptic drugs," Dr. Meador said at the meeting. He pointed to a dose-dependent effect for valproate that was not observed in other drugs.
"This is a difficult study to do and the researchers should be commended for their efforts," Dr. Van Ness said.
Dr. Meador ended his talk saying additional studies are needed to define the risks for other antiepileptic drugs and to disclose underlying mechanisms.
Dr. Meador has received research support from multiple companies, but this study was funded by the National Institutes of Health and the National Institute of Neurological Disorders and Stroke.
AES 2008: American Epilepsy Society 62nd Annual Meeting: Platform session C.07. Presented December 8, 2008
poster:Phillipa
thread:924346
URL: http://www.dr-bob.org/babble/20091029/msgs/924346.html