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FDA Unable to Conclude Risk/Benefit Profile of Stimulant Drugs in Children With ADHD ROCKVILLE, Md -- June 15, 2009 -- The US Food and Drug Administration (FDA) is providing its perspective on data published today in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. Therefore, the FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. The FDA’s summary of the study and its limitations, and our recommendations for healthcare professionals are provided below. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. Use of stimulant medication was determined from parents, medical examiners, and toxicology reports. These 2 groups of children were compared because the children all died suddenly and the cause of death was not a known health problem. Of the 564 healthy children who died suddenly, 10 were reported to be taking a stimulant medication at the time of death. Of the 564 healthy children who died in a motor vehicle accident, 2 were reported to be taking a stimulant medication at the time of death. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Limitations of the study data include: · A child’s use of a stimulant medication for ADHD was determined many years after each child’s death. The deaths occurred between 1985 to1996, but the data on medication usage were collected from March 1997 to January 2008. This time lag may have resulted in reporting errors. · The differences in cause of death (sudden death vs death from a motor vehicle accident) could have influenced the family or caregiver’s recall of information on stimulant medication use at the time of death, creating an elevated rate of stimulant drug use in the group of children who died suddenly, as compared to the children who died in a motor vehicle accidents. · The sudden unexplained death of a child, in comparison to a death of a child from a motor vehicle accident, may have increased the likelihood of a post-mortem inquiry into medication use. · The low frequency of stimulant use in both groups, as well as possible differences in the type of post-mortem inquiry, could have a profound biasing effect on the results. The FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. The Agency for Healthcare Research and Quality (AHRQ) and the FDA are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009. Recommendations for Healthcare Professionals: Follow all the current prescribing information for use of these medications, including: · Take a medical history for cardiovascular disease in the child and his or her family. · Perform a physical exam with special focus on the cardiovascular system (including examination for the signs of Marfan syndrome). · Consider obtaining further tests such as a screening electrocardiogram and echocardiogram if the history or examination suggests underlying risk for or the presence of heart disease. Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: 1-800-FDA-0178 Fax https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm Regular Mail: Use postage-paid FDA Form 3500 MedWatch 5600 Fishers Lane Rockville, MD 20852-9787 SOURCE: US Food and Drug Administration (FDA) E-mail this page to a friend or colleague! To print, use this version