Testimony Given at FDA's Joint Committee Meeting of the Peripheral and CNS Advisory Committee and Psychopharmacologic Advisory Committee
July 10, 2008
Antiepileptic Medication Suicidality Meta-analysis
Division of Dockets Management (HFD-21)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Good afternoon, I am Larry Greenhill, M.D., President-elect of the American Academy of Child and Adolescent Psychiatry (AACAP) a medical membership association of 8,000 child and adolescent psychiatrists established in 1953. The AACAP is the leading national medical association dedicated to treating and improving the quality of life for the estimated 7 - 12 million American youth under 18 years of age who are affected by emotional, behavioral, developmental and mental disorders. We are acutely concerned about the safety of the medications that may be used in treatments and appreciate the FDA Committee’s concern and attention to the suicidality data from antiepileptic medication trials.
The AACAP would like to thank the FDA for holding this hearing. Seizure disorders are serious and potentially fatal. Many patients and their families suffer daily with these disorders. However, when recognized and correctly diagnosed, they can be treated successfully. Effective therapeutic approaches need to be comprehensive and individualized to the needs of the patient.
Adverse psychiatric events for children and adolescents have now been reported in conjunction with the use of various medications. It's challenging, at best, to try and reevaluate data from multiple clinical trials, few of which were actually designed to assess such parameters. Analyses based primarily on a retrospective review of reports, that are not systematically designed to assess causality of suicidal thoughts or behaviors, cannot provide us with adequate information to fully understand the relationship between medications and these adverse events. However, they can raise questions and help inform much needed future research. The data reviewed today, strongly indicates a need for large scale, prospective studies which evaluate the incidence of such side effects in a prospective systematic manner, utilizing consistent assessment tools and techniques.
The AACAP is concerned about the ramifications and impact of the FDA’s recommendations for patient care based on these types of data reports. As we have learned from previous experience, the FDA’s decisions regarding the use of black box warnings significantly influence physicians’ prescribing practices and ultimately patient care. We ask the Committee to carefully consider their message to the public regarding these medications. These medications are helpful and even life saving for many people with neurological disorders, but patients currently on these medications could face life threatening effects if they choose to discontinue their medication without physician involvement.
The AACAP is supportive of the FDA’s practice of approving safe and effective treatments for our patients. We strongly urge the FDA Peripheral and CNS Drugs Advisory Committee and Psychopharmacologic Drugs Advisory Committee to consider all data available on the relationship of antiepileptic medications and suicide when determining decisions about product labeling, and ramifications of actions based on currently available data. While protecting and informing the public, we urge the agency to very carefully weigh the impact of black box warnings on current practice and the demonstrated effectiveness of these medications to treat our patients, and to consider the most beneficial manner by which the recommendations are released to physicians and the general public.