Condom Announcement
Boosted Information for Patients
Additional Information for Healthcare Professionals
Data Summary

Safety Announcement

[11-01-2011] The U.S. Food and Drug Administration (FDA) is updating the public that a large, recently-completed report in children and young adults treated with medication for Attention-Deficit/Hyperactivity Disorder (ADHD) has not shown an association between use of certain ADHD medications and adverse cardiovascular events. These adverse cardiovascular events include stroke, heart assault (myocardial infarction or MI), and sudden cardiac death.

ADHD medications involved in this safety review

Stimulants

  • methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR)
  • dexmethylphenidate HCl (Focalin, Focalin XR)
  • dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat)
  • lisdexamfetamine dimesylate (Vyvanse)
  • amphetamine, mixed salts (Adderall, Adderall XR)
  • methamphetamine (Desoxyn)

Non-stimulants

  • pemoline (Cylert-no longer marketed)
  • atomoxetine (Strattera)

The medications studied include stimulants (amphetamine products and methylphenidate), atomoxetine, and pemoline (no longer marketed).

This written report did not find an association between employ of ADHD medications and cardiovascular events. FDA continues to recommend that healthcare professionals prescribe these medications according to the professional prescribing label.

Healthcare professionals should take special note that:

  • Stimulant products and atomoxetine should generally non be used in patients with serious middle issues, or for whom an increase in blood pressure or heart rate would be problematic.
  • Patients treated with ADHD medications should exist periodically monitored for changes in heart rate or blood pressure.

Patients should continue to use their medicine for the treatment of ADHD as prescribed by their healthcare professional.

This accomplice study, conducted with 1,200,438 children and young adults (aged 2-24 years) and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs, only found vii serious cardiovascular events in current users. Person-years is the total sum of the years that each person in a study has been under ascertainment (for a description of the written report analysis see the study report or article). Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who utilise ADHD medications. The possibility of a small to modest increase in run a risk cannot exist ruled out because of the small-scale number of serious cardiovascular events observed in the patients studied. (see Information Summary)

This is the first of three split up but related studies that were sponsored by the FDA and the Agency for Healthcare Research and Quality (AHRQ). These studies were designed to evaluate the potential increased adventure of heart attack, stroke or sudden cardiac death that could exist associated with the use of ADHD medications. FDA will communicate the results of the other two studies (performed in adults) when our review of the report results is complete.

The terminal study report is being released today: Final Report: Attention Arrears Hyperactivity Disorder Medications and Run a risk of Serious Cardiovascular Disease in Children and Youth disclaimer icon.  FDA is also releasing the Statistical Review of the Last Report for Observational Study: Attention Deficit Hyperactivity Disorder Medications and Run a risk of Serious Cardiovascular Illness in Children and Youth and Addendum: Statistical Review of the Terminal Written report for Observational Study: Attention Arrears Hyperactivity Disorder Medications and Risk of Serious Cardiovascular Disease in Children and Youth.

This study was published in the New England Journal of Medicine on November 1, 2011 and can be viewed heredisclaimer icon.1

With this communication, FDA is providing the Agency'south analysis of the most up-to-engagement data that is currently available to healthcare professionals and families.

Additional Information for Patients or Caregivers

  • Continue your ADHD treatment as prescribed by a healthcare professional person.
  • Talk to your healthcare professional virtually any questions you lot may have near ADHD medications.
  • Immediately see a healthcare professional if yous or the person you are caring for develops breast hurting, shortness of breath, or fainting while taking medication to treat ADHD.
  • Report whatsoever suspected side effects of ADHD medication use to your healthcare professional or to the FDA MedWatch program using the data in the "Contact United states" box at the bottom of the page.

Additional Data for Healthcare Professionals

  • A big retrospective cohort report in children and young adults (aged 2-24 years) did not show an association between use of ADHD drugs and cardiovascular events, which include MI, stroke or sudden cardiac death. These report results were not consequent with the increase in sudden death estimated in a previous study, however a small to modest increase in risk cannot be excluded.2
  • Proceed to prescribe drugs used for the treatment of ADHD according to the professional person prescribing directions.
  • Written report agin events involving ADHD medications to the FDA MedWatch program, using the information in the "Contact Usa" box at the bottom of the page.

Data Summary

A written report past Gould et al. suggesting a higher risk of sudden death in children taking stimulant medications for ADHD was discussed in a previous FDA communication.2

Claret pressure and heart rate increases have been observed in patients treated with the sympathomimetics methylphenidate and amphetamine, and with atomoxetine. In view of these effects, plus spontaneous postmarketing reports of serious cardiovascular events with use of ADHD drugs, FDA (in partnership with AHRQ) sponsored observational studies of serious cardiovascular events with drugs for ADHD. The projection was divided into three separate just related studies. Ane study assessed myocardial infarction (MI), stroke, and sudden cardiac expiry (SCD) with use of ADHD drugs by children and immature adults aged two-24 years. A 2d study assessed MI and SCD among non-elderly developed users (anile 25-64 years). A 3rd study evaluated stroke in not-elderly adult users, which besides included an analysis of the composite endpoint (SCD plus MI plus stroke) in adults.

Each written report was a retrospective cohort report using health intendance claims databases from several sources: Kaiser Permanente, Tennessee Medicaid, Washington State Medicaid, Ingenix, and HMO Research Network. Drug exposures were identified from prescription claims data. Outcomes of stroke, MI, or SCD were identified from diagnoses in claims data, and from searches of vital statistics and death certificate data. Potential cases were either adjudicated from medical records by experts bullheaded to exposure status, or were identified using electronic data example definition algorithms.

This first written report, conducted with 1,200,438 children and immature adults (aged ii-24 years) and ii,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs, merely found vii serious cardiovascular events (4 strokes and 3 sudden cardiac deaths) in electric current ADHD drug users. All vii events occurred in Medicaid patients, although Medicaid patients contributed only virtually half of the total exposed person time.

In comparison to non use, in that location was no clan of serious cardiovascular events with ADHD drug use (adapted hazard ratio 0.75, 95% confidence limits 0.31-one.85). Additional analyses including utilise of a former user reference group did non materially impact the finding of no association with drug exposure. The inferential value of not finding an clan is tempered by the fact that at that place were only seven serious cardiovascular events during ADHD drug exposure (charge per unit of ane.87 events per 100,000 person-years), suggesting a low absolute gamble. This besides express the ability to make statistical comparisons to rates in patients not using ADHD drugs. The results were not consistent with the 7-fold increment in sudden death reported in a case-control study published by Gould et al.,2 just a small to pocket-sized increment in risk cannot exist excluded.

FDA will communicate the results of the other two studies (performed in adults) when our review of the results is consummate.

References

  1. Cooper WO, Habel LA, Sox CM, et al. ADHD drugs and serious cardiovascular events in children and young adults. N Engl J Med 2011. ePub ahead of print. http://www.nejm.org/doi/full/10.1056/NEJMoa1110212. Accessed November 1, 2011.
  2. Gould MS, Walsh BT, Munfakh JL, Kleinman M, Duan N, Olfson M, Greenhill L, Cooper T: Sudden death and use of stimulant medications in youth. Am J Psychiatrydisclaimer icon (published online June 15, 2009; doi:10.1176/appi.ajp.2009.09 040538)

Related Information

  • Communication almost an Ongoing Safety Review of Stimulant Medications used in Children with Attending-Deficit/Hyperactivity Disorder (ADHD)
  • ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults
  • FDA Drug Rubber Podcast for Healthcare Professionals: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
  • Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad de medicamentos usados para el tratamiento del Trastorno de DÃficit de AtenciÃn con Hiperactividad (ADHD por sus siglas en inglés) en niÃos y adultos jÃvenes
  • Information about Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)