02/23/2007

The FDA issued a Public Health Advisory, asking manufacturers to revise the labeling of all CNS stimulants used to treat attention-deficit hyperactivity disorder (ADHD). The labeling change would alert healthcare providers to the risk of cardiovascular or psychiatric adverse effects. Serious cardiovascular adverse events have been reported in patients taking usual doses of ADHD medications, including sudden death in patients with underlying heart problems, and stroke or heart attack in adults with certain risk factors. Drug-related psychiatric adverse events have occurred in 1/1,000 patients with and without previous psychiatric illness, including auditory hallucinations, unwarranted suspicion, and manic behavior.

FDA also informed these manufacturers that a Patient Medication Guide (MedGuide) must be developed for these medications. The MedGuide should be given to patients receiving the drugs to advise them of the risk and precautions that can be taken.

Medications affected include amphetamine/dextroamphetamine (Adderall, Adderall XR), atomoxetine (Strattera), dexmethylphenidate (Focalin, Focalin XR), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA). FDA encourages patients and healthcare providers to work together to develop a treatment plan for ADHD, including a health history, family history, and ongoing monitoring of cardiovascular and psychiatric status.

• FDA MedWatch Alert:
  http://www.fda.gov/medwatch/SAFETY/2007/safety07.htm#ADHD
   
• Drug Information Page:
  http://www.fda.gov/cder/drug/infopage/ADHD/default.htm
   
• FDA Press Release:
  http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html
   
• Amphetamine/dextroamphetamine (Adderall, Adderall XR)
• Revised label:
  http://www.fda.gov/cder/foi/label/2006/011522s034s037,021303s013lbl.pdf
   
• Draft Adderall Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/amphetaminesMG.pdf
   
• Draft Adderall XR Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/amphetaminesXRMG.pdf
   
• Related alert: Amphetamine/dextroamphetamine (Adderall, Adderall XR) associated with sudden death, sales suspended on the Canadian market:
  http://uuhsc.utah.edu/pharmacy/alerts/66.html
• Atomoxetine (Strattera)
• Revised label:
  http://www.fda.gov/cder/foi/label/2006/021411s018lbl.pdf
   
• Draft Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/atomoxetineMG_draft.pdf
• Dexmethylphenidate (Focalin, Focalin XR)
• Revised Focalin label:
  http://www.fda.gov/cder/foi/label/2006/021278s004_005lbl.pdf
   
• Draft Focalin Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/dexmethylphenidate_Ftablets.pdf
   
• Revised Focalin XR label:
  http://www.fda.gov/cder/foi/label/2006/021802s007s003lbl.pdf
   
• Draft Focalin XR Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/dexmethylphenidateXRMG.pdf
• Dextroamphetamine (Dexedrine)
• Revised Label:
  http://www.fda.gov/cder/foi/label/2006/017078s040lbl.pdf
   
• Draft Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/dextroamphetamineMG.pdf
   
• Dextroamphetamine (Dexedrine, Dexedrine Spansule) Labeling Changes, Including Sudden Death:
  http://uuhsc.utah.edu/pharmacy/alerts/173.html
• Methamphetamine (Desoxyn)
• Revised label: not yet available
   
• Draft Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methamphetamine_DHCLMG.pdf
• Methylphenidate (Concerta, Daytrana, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA)
• Revised Concerta label:
  http://www.fda.gov/cder/foi/label/2006/021121s009s012lbl.pdf
   
• Draft Concerta Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidate_C_HCLMG.pdf
   
• Revised Daytrana label:
  http://www.fda.gov/cder/foi/label/2006/021514s001lbl.pdf
   
• Draft Daytrana Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidate_transdermalMG.pdf
   
• Revised Metadate CD label:
  http://www.fda.gov/cder/foi/label/2006/021259s018lbl.pdf
   
• Draft Metadate CD Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidate_MetaXRMG.pdf
   
• Revised Methylin oral solution label:
  http://www.fda.gov/cder/foi/label/2006/021475s002,021419s003lbl.pdf
   
• Draft Methylin oral solution Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidate_MoralMG.pdf
   
• Revised Methylin chewable tablets label:
  http://www.fda.gov/cder/foi/label/2006/021475s002,021419s003lbl.pdf
   
• Draft Methylin chewable tablets Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidate_MchewMG.pdf
   
• Revised Ritalin label:
  http://www.fda.gov/cder/foi/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf
   
• Draft Ritalin Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidate_RtabletsMG%20.pdf
   
• Revised Ritalin LA label:
  http://www.fda.gov/cder/foi/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf
   
• Draft Ritalin LA Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidateR_XRMG.pdf
   
• Revised Ritalin SR label:
  http://www.fda.gov/cder/foi/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf
   
• Draft Ritalin SR Patient Medication Guide:
  http://www.fda.gov/cder/Offices/ODS/MG/methylphenidateR_SRMG.pdf

The FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. This requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1). However, it may be appropriate to educate inpatients about the potential hazards of prescription medications, at the clinician’s discretion. The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/cder/Offices/ODS/labeling.htm.