New Warnings Proposed for ADHD Medications

Lake Park Pediatrics, University of Chicago
Maureen Grundy Medical Student III 2/28/06
Yingshan Shi, M.D. (773) 702-2600 3/05/06, 04/06/06, 04/23/2006

Block box not needed on ADHD medications.
The original adapted from Infectious Diseases in Children and Pediatric News April, 2006
"New warning OK for ADHD drugs, but no black box". The FDA's pediatric advisory committee said that a reported risk for cardiovascular complications was not strong emough in children to merit a black box label.

In February 2006, an advisory committee for the FDA met to evaluate the safety of Attention Deficit-Hyperactivity Disorder (ADHD) stimulant medication, such as amphetamines and methylphenidate. The committee looked at data of children taking stimulant medication between 1999 and 2003. The data showed that during that time, 18 non-fatal cardiac related problems and 12 deaths in children and adolescents taking an amphetamine containing medication were reported to the FDA. For children and adolescents taking methylphenidate, there were 7 sudden deaths and 8 non-fatal cardiac related problems. This translates into 0.36 deaths per 1 million amphetamine prescriptions written and 0.21 deaths per 1 million methylphenidate prescriptions written.

As a result of this information, the committee majority made 2 recommendations:

1. A medication guide should be made available to all families and patients
2. A “black box” warning should be added to the labeling of methylphenidate and amphetamine containing medication that these medications may cause an increase in blood pressure and may lead to heart attack, stroke, and/or sudden death

Which medications would carry the warning label?

1. Methylphenidates: Ritalin, Concerta, Methylin, and Metadate
2. Amphetamines: Dexedrine, Adderall, Adderall XR

What do these recommendations mean?

The recommendations made so far are based on observations of large number of children and adolescents taking these commonly prescribed medications for ADHD. The data can not say for sure that the sudden deaths and cardiac problems experienced by some of these children were definitely caused by the medications. The next step in evaluating the safety of these medications is to look more closely at the data to determine if these unfortunate events are indeed caused by the medications. In the meantime, the FDA advisory committee feels it is important that patients and their doctors are aware of the potential risks associated with these medications.

What if my child is currently taking one of these medications?

These medications are commonly prescribed for children with ADHD and many studies have shown them to be effective in the short-term management of ADHD symptoms. Less information is available on the long-term safety and efficacy of these medications. Some of the known side effects of these medications include anorexia, appetite disturbance, and weight loss. Less common side effects include headache, nervousness, irritability and increased heart rate and blood pressure.

It is important that you and your child’s doctor discuss the potential risks associated with these medications. If your child is currently taking one of these medications, do not stop or change it without first talking to your child’s doctor. It is important that your child’s doctor is aware of any history of heart problems, heart murmurs, or fainting in your child or your family and any history of sudden death in your family as well. Your child’s doctor should also regularly follow your child’s pulse and blood pressure when taking these medications.

What should physicians and parents do now?
At this time, information about potential harm caused by the medications is very limited and incomplete. It is important for patients and physicians to look at both the benefits and risks when making treatment decisions for ADHD. Physicians should continue to follow AAP guidelines on the assessment and management of ADHD, and also follow up the further information of the black box warning on ADHD stimulant medications.

http://www.aap.org/family/safetypillsadhd.htm download a handout for parents on the safety of ADHD stimulant medications
Ask your physicians for more information

References:
http://www.aboutourkids.org ( NYU Child Study Center )
http://www.aacap.org (The American Academy of Child and Adolescent Psychiatry)
AAP “Clinical Practice Guideline: Treatment of School-Aged Child with Attention-Deficit/Hyperactivity Disorder.” 108:4 October 2001
AAP news April 2006
Infectious diseases in Children April, 2006