FDA Hearing : Cardiovascular Safety of ADHD Medications in Children & Adolescents M. Christopher Griffith, M.D. Clinical Assistant Professor: Emory University School of Medicine Morehouse School of Medicine

Introduction Dr Griffith’s experience in the evaluation and treatment of children’s mental health conditions. Dr Griffith’s experience in the evaluation and treatment of children’s mental health conditions. Practical/clinical experience with ADHD Practical/clinical experience with ADHD

Cardiovascular Safety General and cardiovascular safety concerns are the highest importance when ADHD medications are prescribed for children and adolescents. General and cardiovascular safety concerns are the highest importance when ADHD medications are prescribed for children and adolescents. Medications for the treatment of ADHD— (Stimulant & non-stimulant) are safe & effective in children & adolescents. Medications for the treatment of ADHD— (Stimulant & non-stimulant) are safe & effective in children & adolescents. Cardiovascular side effects are generally mild and rarely severe. Cardiovascular side effects are generally mild and rarely severe.

The Most Common Challenge? The Most Common Challenge? Each day as a Child & Adolescent Psychiatrist, I am challenged more commonly with the dangerous and often lethal complications of failing to recognize and treat ADHD……… Rather than cardiovascular side-effects! Each day as a Child & Adolescent Psychiatrist, I am challenged more commonly with the dangerous and often lethal complications of failing to recognize and treat ADHD……… Rather than cardiovascular side-effects!

Recognizing ADHD: The next series of challenging ?’s…Hopefully paints a picture for you on: The next series of challenging ?’s…Hopefully paints a picture for you on: 1. What this condition often masquerades itself ? 2. Urgency in regards to evaluation and early symptom recognition ? 3. The risk/benefit ratio of treatment vs. not? 4. The passion that my colleagues and I share for treating children & adolescents with ADHD

The Questions to consider? What happens when : What happens when : A child loses all hope and ambition? A child loses all hope and ambition? It is easier to find a 40 oz., a vial of crack cocaine----rather than a park or recreation center? It is easier to find a 40 oz., a vial of crack cocaine----rather than a park or recreation center? A future generation of minority youth----Latino & African-American young men,disproportionately fill the juvenile justice system? A future generation of minority youth----Latino & African-American young men,disproportionately fill the juvenile justice system? To teenager’s sense of “FUN”.. When dealing with higher rates of pregnancy, abortion, and sexually transmitted diseases? To teenager’s sense of “FUN”.. When dealing with higher rates of pregnancy, abortion, and sexually transmitted diseases? Finally what does it say about us all…when we face countless number of automobile fatalities in young drivers…so many that we have developed a sense of apathy by forgetting their names and faces!

Clinical Consequences/Co-morbidity with Untreated ADHD Higher rates of: Higher rates of: -school & occupational failure -school & occupational failure -delinquency and incarceration -delinquency and incarceration -substance abuse -substance abuse -teen pregnancy -teen pregnancy -STD’s -STD’s -depression/self esteem -depression/self esteem -automobile fatalities -automobile fatalities

Disparities in Treatment The greatest obstacles in the safety & usage of medication for ADHD in my observation are: The greatest obstacles in the safety & usage of medication for ADHD in my observation are: 1) The progressive deterioration and lack of access to quality and comprehensive mental health services!...Including access to medications! 1) The progressive deterioration and lack of access to quality and comprehensive mental health services!...Including access to medications! 2) Misinformation and lack of education on ADHD and other mental health disorders 2) Misinformation and lack of education on ADHD and other mental health disorders These findings are reported in the Surgeon General’s Report on Mental Health from These findings are reported in the Surgeon General’s Report on Mental Health from The greatest disparities in health care services,perhaps, have been identified in treating minority populations and in rural areas. The greatest disparities in health care services,perhaps, have been identified in treating minority populations and in rural areas. The treatment of these populations is restricted by access to care- often governed by economic and/or geographical constraints. The treatment of these populations is restricted by access to care- often governed by economic and/or geographical constraints.

Safety/Summary Safe medications, especially related to cardiovascular events, is of the highest priority for physicians and for patients that we treat! Safe medications, especially related to cardiovascular events, is of the highest priority for physicians and for patients that we treat! Clinical judgment & wisdom as a physician--- comes through life long learning and thousands of hours of experience. Clinical judgment & wisdom as a physician--- comes through life long learning and thousands of hours of experience. For each doctor this special talent & skill remains the most valuable weapon in our arsenal as we treat ADHD and health conditions. For each doctor this special talent & skill remains the most valuable weapon in our arsenal as we treat ADHD and health conditions.

Summary (cont.) Medications for the treatment of ADHD— (Stimulant & non-stimulant) are safe & effective in children & adolescents. Medications for the treatment of ADHD— (Stimulant & non-stimulant) are safe & effective in children & adolescents. Cardiovascular side effects are generally mild and rarely severe. Cardiovascular side effects are generally mild and rarely severe. Please keep in mind…..the dire consequences of failing to recognize & treat. Please keep in mind…..the dire consequences of failing to recognize & treat.

Closing Message CHADD & membership of the NMA respectfully request that no additional restrictions be placed upon these medicines. CHADD & membership of the NMA respectfully request that no additional restrictions be placed upon these medicines. The health and welfare of the patient’s in the highest need would be adversely affected by additional warning labels or restriction in use. The health and welfare of the patient’s in the highest need would be adversely affected by additional warning labels or restriction in use.