NEW ORLEANS, Dec. 7 /PRNewswire/ -- Women taking central nervous system (CNS) active medications commonly known as anticonvulsants or antiepileptic drugs (AEDs) -- for epilepsy, migraines, bipolar disorders or other medical conditions -- need to be aware of the differential risk for birth defects potentially caused by these drugs before they become pregnant. There is now statistically significant data emerging about the relative degrees of birth- defect risk associated with specific AEDs, as reported at the American Epilepsy Society’s (AES) First Annual Pregnancy Outcome Forum.
This information is relevant to a growing number of American women -- and the physicians who treat them -- as more than 56 million AED prescriptions were issued in a 12-month period ending September 2004, according to Scott- Levin’s NRx Monthly AED market report.
Converging data from five antiepileptic drug registries suggest that two older AEDs, sodium valproate and phenobarbital, are associated with an increased risk of birth defects and developmental disorders. These registries, established between 1992 and 1999, help provide post-marketing surveillance of the comparative incidence of major fetal malformations after use of AEDs during pregnancy. Specifically, data released from the North American Antiepileptic Drug Pregnancy Registry found a significantly increased risk -- 10.7 percent rate -- of major birth defects in babies born to women who had taken valproate. The same registry also found a 6.5 percent rate of major malformations in babies born to women who had been exposed to phenobarbital.
Early data suggests that some newer AEDs pose less risk. “For example, new statistically significant data suggests that one of the newer-generation AEDs, lamotrigine, is showing great promise of presenting no greater risk of major congenital malformations than that found in the general population,” noted Dr. Martha Morrell, Clinical Professor of Neurology at Stanford University. She added, “We hope that additional information will be available soon about the other newer AEDs. Then, we’ll be in a better position to understand how to use them with the women in childbearing age.”
Based on the convergence of this new data, the Epilepsy Foundation and AES have committed to work together to identify trends in the data and share the findings, with their patient and physician constituencies.
“This forum helps bring pregnancy registries to the forefront of clinical practice. Importantly, however; a critical component for success is the enrollment of more women,” added Dr. Lewis Holmes, Professor of Pediatrics at Harvard Medical School and Director of the North American Antiepileptic Drug Pregnancy Registry.
Women of childbearing age taking AEDs are encouraged to work with their physicians to determine what, if any, changes in medication may be required. This is important given that 50 percent of pregnancies are unplanned; data suggests that women in their reproductive years need to think more about their drug treatments should they become pregnant. Hormonal contraceptives and pregnancy also can impact the effectiveness of some AEDs, thereby requiring dose adjustments. Women should consult with their doctor before making any changes in their medication.
“This is a significant advance from where we were just a few years ago,” noted Morrell. “The convergence of this data indicates that not all AEDs are equal to women of child-bearing age. And, although the methodology of the pregnancy registries differ and therefore cannot easily be combined to achieve a greater statistical conclusion, these analyses need to be given serious attention. We would be doing our patients a disservice if we didn’t use these data trends to revisit treatment options for those who are pregnant or may become pregnant,” added Dr. Morrell.
Experts acknowledge that ongoing registration and analyses of data is essential, as it will enhance the registries’ statistical power, helping physicians assess benefit-risk ratio of AED in pregnancy. According to Dr. Gregory L. Barkley, Associate Professor of Neurology at Wayne State University and Chair of the Epilepsy Foundation’s Professional Advisory Board and an AES Board Member, “This is the first step of this worldwide cooperative effort to address the public health needs of millions of women and their unborn children by reporting findings as they become available.”
Dr. Barkley announced the Epilepsy Foundation’s new yearlong initiative designed to share post-marketing data with women who are either pregnant or thinking of becoming pregnant, and their physicians. The goal of this program is to alert women undergoing AED treatment of this information and to provide medical professionals with the resources to help them distinguish among the risks of different AEDs.
AES is also committed to providing ongoing analyses of the data from the pregnancy registries and will submit its findings for publication in professional journals. The two organizations review data from the following registries: Australian Pregnancy Registry of Women Taking Antiepileptic Drugs; The International Lamotrigine Pregnancy Registry Update; European Registry of Antiepileptic Drugs (EURAP); North American Antiepileptic Drug Pregnancy Registry; and the U.K. Epilepsy and Pregnancy Group.
A clear call to action resonated at the scientific conference. Many more women need to enroll in registries to continue the collection of useful data. To make it easier for women to learn more about the registries and to enroll, the Epilepsy Foundation has updated its Web site -- http://www.epilepsyfoundation.org/ -- with a link to the North American registry, which is maintained out of the Genetics and Teratology Unit of Massachusetts General Hospital in Boston. Women who enroll will be asked to provide information about the health status of their children and all information will be kept confidential. Additionally, the North American Antiepileptic Drug Pregnancy Registry encourages women who are taking AEDs to call 1-888-233-2334 early in pregnancy to register.
Epilepsy Foundation
The Epilepsy Foundation, with national offices in metropolitan Washington, D.C., and a network of local affiliates throughout the nation, is the leading volunteer organization devoted to research, education, advocacy and the provision of services in the community for people with seizure disorders and their families. For more information, visit http://www.epilepsyfoundation.org/, or call 1-(800)-332-1000.
The American Epilepsy Society
AES is one of the oldest neurological professional organizations in the nation, with roots dating to 1898. The Society promotes research and education for professionals dedicated to the prevention, treatment and cure of epilepsy. Membership in the Society is made up of clinicians, researchers investigating basic and clinical aspects of epilepsy, and other health-care professionals interested in seizure disorders. Members represent pediatric and adult sides of epilepsy. For more information, visit http://www.aesnet.org/.
Sidebar story data
The Epilepsy Foundation and American Epilepsy Society strongly urge women who are taking AEDs to:
* Talk with their doctor before becoming pregnant about AED risks and treatment options that may lower the risk of birth defects in advance of pregnancy; * Be aware that multiple AED therapy has been associated with an increased rate of birth defects; * Routinely have their AED blood levels monitored as their doctor may chose to alter doses, as appropriate; * Take a multivitamin supplement with folic acid before conception and throughout pregnancy because it may play a part in reducing the risk of birth defects; * Stay on top of emerging information and data about AEDs; * If pregnant, enroll early in a pregnancy registry to add to the body of knowledge and help other mothers and babies; * Do not reduce or discontinue medication without advice from a doctor, as seizures could do more harm to the unborn child than AEDs; and * Consult a doctor to find the medication that works best for them-i.e., balances seizure risk against birth-defect risk.
This Epilepsy Foundation program and the media briefing are supported in part by an education grant from GlaxoSmithKline.
The American Epilepsy Society’s press room and resources are supported by an education grant from UCB Pharma, Inc.
Epilepsy Foundation
CONTACT: Christer Osterling of American Epilepsy Society,+1-860-508-9433, costerling@aesnet.org; or Peter Van Haverbeke of EpilepsyFoundation, +1-301-918-3772, +1-301-526-9373, pvanhaverbeke@efa.org