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FDA Issues Public Health Advisory and Warning on Strattera
Yesterday, September 29th, the Food and Drug Administration issued a Public Health Advisory on Strattera. This advisory is to alert physicians of reports of suicidal thinking in children and adolescents associated with Strattera. The FDA recommended that children and adolescents taking Strattera "shoud be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed."
The FDA has also directed the company that manufactures Stattera, Eli Lilly and Company, to develop a Medication Guide for patients and their caregivers.
Strattera was approved in 2002 to treat ADHD and has been used in over two million patients. It is a selective norepinephrine reuptake inhibitor (SNRI) and the first FDA-approved non-stimulant to treat ADHD. It is presumed to work by blocking or slowing reabsorption of norepinephrine, a chemical in the brain considered important in regulating attention, impulsivity and activity levels (core symptoms of ADHD). This makes more norepinephrine available in neuronal synapses. Improved efficiency in the norepinephrine system is associated with improvement in symptoms of ADHD.
The action taken by the FDA is a result of a review and analysis of 12 clinical trials involving children with ADHD and one trial in children with enuresis. These trials identified that there was an increased risk of suicidal thinking when taking Strattera. In these trials, 1350 patients received Strattera and 851 received a placebo. The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo. The FDA requested that Eli Lilly & Company review its database and clinical trials.
Eli Lilly & Company announced that it will update the product label globally for Strattera to communicate new information regarding uncommon reports of suicidal thoughts among children and adolescents. In the United States, Eli Lilly will add a boxed warning to the product label and is working with the FDA to finalize the product label content as well as information for healthcare professionals.
What should parents whose children or teens take Strattera do?
First, don't panic. Have a talk with the prescribing doctor to find out more information about this advisory. Talk with your child or teen about how he or she feels when taking the medication. Remember, although this is an uncommon finding, it should be taken seriously. It is important for parents and doctors to consider the risks and benefits of all medications given to children and to plan a comprehensive treatment program for ADHD that includes non-medical interventions as well.
For more information about this new FDA warning visit:
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01237.html
http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=175142
Research Updates
Incidence of ADHD Secondary to Traumatic Brain Injury
Secondary ADHD (SADHD) refers to the development of ADHD after brain injury. Studies have found that the rates of to vary between 19% and 20% following traumatic brain injury (TBI). A recently published study (Max, J.E., et al 2005) examined the occurrence of SADHD after TBI. Children without pre-injury ADHD 5 to 14 years old with TBI from consecutive admissions to five trauma centers were observed prospectively for six months. Injury severity, lesion characteristics, and pre-injury variables including psychiatric disorder, family psychiatric history, family psychiatric history of ADHD, family function, SES, psychosocial adversity and adaptive function were assessed with standardized instruments. Investigators found that SADHD in the first 6 months after injury occurred in 16% of returning participants. All subtypes of ADHD occurred. The investigators concluded that the occurrence of SADHD is an important and relatively common complication of TBI in children between 6 and 24 months after TBI, that pre-injury family psychosocial adversity is associated with increased risk of SADHD, and that the child's pre-injury adaptive function is a predictor of SADHD in the medium- and long-term. Severity of injury was not associated with SADHD at any point in the 2- year follow-up study.
Max, J.E., Schachar, R.J., Levin, H.S., Ewing-Cobbs, L., Chapman, S., Dennis, M., Saunders, A., & Landis, J. (2005). Predictors of secondary attention-deficit/hyperactivity disorder in children and adolescents 6 to 24 months after traumatic brain injury. J. Am. Acad. Child Adolesc. Psychiatry, 44:10, 1041-1049.
PET Findings for Men with ADHD Treated with Methylphenidate
A recent issue of The ADHD Report (April 2005) discussed the findings of a study that looked at differences in positron emission tomography (PET) measures in regional cerebral blood flow during the Paced Auditory Serial Addition Task in 10 men with ADHD and 11 controls after three weeks of treatment with methylphenidate (MPH). MPH treatment was associated with increased resistance to distractors in the task for the ADHD group and reduced activity in the pre-frontal cortex during task performance. Increased activity was also observed in motor areas which may correspond to an increased preparedness to respond to stiumli. No increases were observed in the anterior cingulated cortex, a brain region associated with the inhibition of responding to inappropriate stimuli. Furthermore, increases in the cerebellum and basal ganglia were significantly higher in the ADHD group, suggesting that these participants may have recruited alternative brain regions to perform the task. MPH was associated with improved task performance, but it did not normalize the brain pathways used to perform the task.
Schweitzer, J.B. et al. (2004). Effects of methylphenidate on executive functioning in adults with attention-deficit/hyperactivity disorder: Normalization of behavior but not related brain activity. Biological Psychiatry, 56, 597-606.
October's Featured myADHD.com's Tools
Parents of children and adolescents with ADHD can benefit from using this month's treatment tools. These tools focus on social skills for children. Worksheets are provided to help children use cognitive-behavioral strateges to manage anger.
· Forgiving Others
· Identifying Thoughts and Feelings That Lead to Anger
· Changing Angry Thoughts to Calm Thoughts
· Using Self-Talk to Manage Problems
Subscribe to MyADHD.com today and view more MyADHD.com Reward Tickets and over 150 other Treatment Tools, Assessment Tools, and Tracking Tools for children, adolescents and adults.
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CHADD Annual Conference
See information about the CHADD Annual Conference in Dallas (October 26-29, 2005). Visit www.chadd.org.
Need to fulfill your continuing education requirements?
See the National Association for Continuing Education for home study programs and live conferences. Over 80 home study courses for psychologists, social workers, marriage and family counselors, and mental health counselors.
For additional articles and resources on ADHD visit these sites:
myADHD.com online library:
www.myadhd.com/librarytools.html
A.D.D. WareHouse--
See our special sales for October 2005
www.addwarehouse.com
To sign up for a live conference on ADHD visit www.addconsults.com
Attention Deficit Disorder Association (ADDA)
www.add.org
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myADHD.com news is an e-publication of Health Link Systems, Inc. This publication is sponsored by myADHD.com, A.D.D. WareHouse, and the National Association for Continuing Education. Information presented here is not intended to replace the advice of a physician or other health care professional. Placement of an advertisement in this e-newsletter does not represent an endorsement of any advertised products or services or the validity of any claims advertised. Copyright 2005 by Health Link Systems, Inc. For comments or information, please send an email to: info@myadhd.com, subject line: myADHD.com News.
