This update is in follow-up to the FDA Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Safety Announcement
Additional 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 study 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 attack (myocardial infarction or MI), and sudden cardiac death.

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

This study did not find an association between use 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 not be used in patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic.
• Patients treated with ADHD medications should be 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 cohort 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 7 serious cardiovascular events in current users. Person-years is the total sum of the years that each person in a study has been under observation (for a description of the study analysis see the study report or article [link]). Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who use ADHD medications. The possibility of a small to modest increase in risk cannot be ruled out because of the small number of serious cardiovascular events observed in the patients studied. (see Data Summary)

This is the first of three separate 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 risk of heart attack, stroke or sudden cardiac death that could be 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 study results is complete.

The final study report is being released today: Final Report: Attention Deficit Hyperactivity Disorder Medications and Risk of Serious Cardiovascular Disease in Children and Youth.  FDA is also releasing the Statistical Review of the Final Report for Observational Study: Attention Deficit 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 here.¹  

With this communication, FDA is providing the Agency’s analysis of the most up-to-date information 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.
• Talk to your healthcare professional about any questions you may have about ADHD medications.
• Immediately see a healthcare professional if you or the person you are caring for develops chest pain, shortness of breath, or fainting while taking medication to treat ADHD.
• Report any suspected side effects of ADHD medication use to your healthcare professional or to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals

• A large retrospective cohort study 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 study results were not consistent with the increase in sudden death estimated in a previous study, however a small to modest increase in risk cannot be excluded.²
• Continue to prescribe drugs used for the treatment of ADHD according to the professional prescribing directions.
• Report adverse events involving ADHD medications to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Data Summary

A study by 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 

Blood 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 project was divided into three separate but related studies. One study assessed myocardial infarction (MI), stroke, and sudden cardiac death (SCD) with use of ADHD drugs by children and young adults aged 2-24 years. A second study assessed MI and SCD among non-elderly adult users (aged 25-64 years). A third study evaluated stroke in non-elderly adult users, which also included an analysis of the composite endpoint (SCD plus MI plus stroke) in adults.

Each study was a retrospective cohort study using health care 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 blind to exposure status, or were identified using electronic data case definition algorithms.

This first 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 7 serious cardiovascular events (4 strokes and 3 sudden cardiac deaths) in current ADHD drug users. All 7 events occurred in Medicaid patients, although Medicaid patients contributed only about half of the total exposed person time.

In comparison to non use, there was no association of serious cardiovascular events with ADHD drug use (adjusted hazard ratio 0.75, 95% confidence limits 0.31-1.85). Additional analyses including use of a former user reference group did not materially affect the finding of no association with drug exposure. The inferential value of not finding an association is tempered by the fact that there were only seven serious cardiovascular events during ADHD drug exposure (rate of 1.87 events per 100,000 person-years), suggesting a low absolute risk. This also limited the ability to make statistical comparisons to rates in patients not using ADHD drugs. The results were not consistent with the 7-fold increase in sudden death reported in a case-control study published by Gould et al.,² but a small to modest increase in risk cannot be excluded.

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

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 Psychiatry (published online June 15, 2009; doi:10.1176/appi.ajp.2009.09 040538)

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Thank you to Dr. Andrew Adesman of North Shore/LIJ

The ADHD Medication Guide© is a visual aid for professionals caring for individuals with ADHD. The guide includes only medications indicated for the treatment of ADHD by the FDA. In clinical practice, this guide may be used to assist patients in identifying medications previously tried, and may allow clinicians to identify ADHD medication options for the future.

CLICK > ADHD Medication Guide©

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3. An Informed Decision: Medication

As a resident of New York, you and your family have access to a statewide Prescription Assistance Program (PAP). Create and print your FREE discount prescription drug card below. This card will provide you with Rx medication savings of up to 75% at more than 56,000 pharmacies across the country including A&P, CVS/pharmacy, Hannaford, Kinney, Kmart, Pathmark, Stop and Shop, Target, Tops, Waldbaums, Walgreens, Walmart, Wegmans, and many more. You can create as many cards as you need. We encourage you to give cards to friends and family members.

Go to:  http://www.newyorkrxcard.com/index.php

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Learn from Glen S. Hirsch, M.D., a nationally recognized expert in diagnosis and psychopharmacology, how a psychiatrist diagnoses this disorder, when and how the question of medication comes into play and, if appropriate, how the choice of a specific medication is made, how to titrate for maximum benefit and how to determine whether the medicine is working at maximum potential.
1. This is an audio recording only (We apologize for the poor recording quality.)

2.  Accompanying PDF of the presentation

Dr. Hirsch is the Medical Director of the NYU Child Study Center & Dept. of Child and Adolescent Psychiatry Assistant Professor of Child and Adolescent Psychiatry, Psychiatry and Pediatrics, NYU School of Medicine.

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Here is a  resource for small businesses, consumers,and their families to search for  health insurance coverage options.

http://www.healthcare.gov/widget/healthcare_widget.html

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While the benefits of medication for ADHD have been shown through numerous well designed studies, medication alone rarely addresses the full range of issues caused by this complex neurobiological condition. This talk will review research regarding behavioral interventions, parenting and educational approaches, along with a discussion of evidence for or against various popular complementary practices.

Note: CHADD’s special membership offer expires at the close of this meeting.  Do not miss this opportunity to save big on membership.

65 East 89th Street.  -  New York City -  March 8th.    -  5:55PM – promptly

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From: National Resource Center

This FAQ was prompted by questions about interactions some young people have had with police and other law enforcement agencies.  Law enforcement officers are vigilant about prescription medication abuse, especially among teenagers and young adults. If you come to the attention of the police for another problem such as a traffic violation or disorderly conduct, and you are carrying AD/HD medication in an unmarked container, you may be at greater risk of being suspected of illegal use of a controlled substance.

What is a “controlled substance”?

A “controlled substance” is defined as any chemical substance or its chemical precursor whose manufacture, possession, or use is controlled and regulated by law.

What is the Controlled Substances Act?

The Controlled Substances Act (CSA; Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 USC Sec. 812) identifies those substances which are considered “controlled substances” in the United States and which are subject to strict regulation. The CSA has a 5-level “Schedule” that identifies which drugs or substances are considered to be “controlled substances” and thus subject to this regulation. A particular substance is assigned to one of these Schedules (I – V) based on its potential for abuse. The CSA identifies many substances, including those which are considered “illegal drugs” or “street drugs,” along with numerous medications that treat a variety of medical and psychological conditions, but which also may be subject to misuse. (For more information, see Medication Diversion.)

The CSA is a federal law and provides a baseline set of standards that apply throughout the United States. Individual states may have expanded lists of medications, more rules regarding who and how medication is dispensed or carried or higher penalties for noncompliance.

Are AD/HD medications considered “controlled substances”?

Yes, most medications used to treat AD/HD7mdash;including the various formulations of methylphenidate and amphetaminemdash;are considered controlled substances.  This is why most prescriptions for AD/HD medications are typically not for more than 30 days.  Most AD/HD medications are classified as Schedule II (see Note below) substances. (Among other criteria, a substance is classified as Schedule II if the “(a)buse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.”)

Is it illegal to carry AD/HD medications?

No, it is generally not considered illegal to carry AD/HD medication as long as the person carrying the medication is the person for whom the medication has been properly prescribed. However, depending on the state in which one lives (e.g. New York), state law may require that the medication be carried in the original prescription bottle with a current label that identifies the person for whom the medication is intended.

In other states, proof of prescription is generally considered sufficient.

If I’m concerned about this, what should I do?

1. Know the law in your state (we are currently researching these and will provide resources soon).
2. For everyday purposes, only carry your medication outside the home if absolutely necessary.
3. If you need to carry your medication with you, it’s best to carry it in its original prescription bottle that clearly identifies the patient’s name and date of prescription.
4. It may also be advisable to carry a copy of your most recent prescription from your physician.
5. If traveling away from home – especially internationally – be sure to take your medication in its original bottle, take only the amount of medication you will need, and carry a copy of your current prescription.

http://www.help4adhd.org/faq.cfm?fid=42&varLang=en

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To View this Document Download the PDF Here

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What you should know about ADHD symptoms and treatment before talking with your doctor about a diagnosis and treatment.

by Harold Robert Meyer and Susan Lasky

When you suspect you have attention deficit disorder (ADD ADHD) and go to a clinician for a diagnosis, it’s best to walk in with some initial understanding of treatment and knowledge about what should happen—now and long-term. Harold Meyer, director of the New York City chapter of CHADD, offers these tips:

1. Be specific in describing your problems. Figure out what concerns you want to address in your consultation. For instance: “At work, I find that I can’t stay on task or complete projects.” “I get so caught up in minute details that I forget to do important things.” “I can’t find anything at home.” “I’m constantly late for appointments, if I remember to go at all.”
2. Consider your stance on medication before your appointment. If you’re opposed to taking medication, state your philosophy up front and ask your doctor if he can recommend other treatment options. If he insists on writing a prescription despite your aversion to medication, don’t be afraid to see someone else. Then, if you have decided on medication, remember that the prescription process varies with the individual. It’s likely that you’ll need to try more than one brand and experiment with different dosages to find the right one for you.
3. Ask the doctor to talk about meds. You want someone who will not just write a prescription, but who will also discuss the diagnosis and treatment with you. These questions should be addressed: What medications are under consideration? Why start with a particular medication? What can you expect to happen? How should you evaluate the effect of the medication?
4. Discuss follow-up. Your doctor should lay out a course of action, including treatment and follow-up appointments. Make sure that he’s accessible. You’ll need to talk with him on the phone in the weeks following the diagnosis as you work to find the right medication dosage. Will he be available? Will he charge you to consult? Will he prescribe medication refills by phone, or do you need to go to his office every time you’re running low?
5. Learn about alternatives to medication. Find out about behavioral therapies and modifications you might try. Can your doctor work with you on these? Is your doctor sympathetic to non-medical treatment? You may benefit from a referral to a psychologist who can offer behavioral help, such as ways to deal with problems at work, time-management techniques, and so on.
6. Ask if he will meet with your family. A diagnosis of ADHD affects those you live with. Your spouse and children need to learn about the condition and how you will manage it. In fact, people with ADHD are not good at observing their own behavior, so it’s best to have someone close to you monitor your behavior while on medication and let you know if they observe changes. Many with ADHD claim that their medication isn’t doing anything, while those around them report marked improvements in various behaviors.
   
   by Harold Robert Meyer and Susan Lasky

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Going off ADHD medication is not uncommon. How you approach the decision makes all the difference in your ADHD treatment.

by Carl Sherman, Ph.D.

I made a huge mistake. I went off my ADHD meds, cold turkey.

For most people who have attention deficit hyperactivity disorder (ADD ADHD), medication is a fact of life. So is going off medication — or at least wanting to. Taking pills day in and day out can feel like a big bother.

People opt out of ADHD medication for all sorts of reasons, often without the consent of their doctors. Some people believe they have outgrown the need for medication. Some worry that long-term use of ADHD drugs is unsafe (something that so far has not been proven). Others go drug-free because they dislike feeling that they are “controlled” by medication.

“Clients tell me that they don’t like the way drugs make them feel,” says ADDitude consultant Michele Novotni, Ph.D., a psychologist in Wayne, Pennsylvania. “They say it stifles their creativity and spontaneity — and that they feel like impostors, not their real selves.”

Teenagers, fueled by rebellion and often impulsive, are especially likely to stop ADHD medication. That was the case with Sara Brooks, of Portland, Oregon. Sara had been a happy young woman and a capable student until her junior year of high school.

“Then she hit a wall,” recalls her mother, Debra Brooks, a clinical social worker and business consultant. “The traumas of adolescence, the lack of formal structure in her advanced classes… she started flunking, got depressed, and gave up.”

A diagnosis of ADHD and six months of medication later, Sara was back on top. She was captain of the cheerleading squad. She had won a college scholarship and landed a berth in an exchange program in Costa Rica. Then, midway through her senior year, things fell apart again. “Sara was wild, cranky, arguing constantly,” says Debra. “In school, she was doing zero. I had a rebellion on my hands.”

Sara finally ‘fessed up: “I made a huge mistake. I went off my meds, cold turkey. I was doing so well, I figured I didn’t need them.” Soon after going back on medication, Sara was happy again — and back on track for college and Costa Rica.

Quit While You’re Ahead?

Many people who choose to go off medications do so because, like Sara, they “feel good.” They wonder: Might I feel just as good — maybe even better —  if I went off the drugs?

That’s not a bad question, says Timothy Wilens, M.D., associate professor of psychiatry at Harvard Medical School. But, he says, there’s a right way and a wrong way to discontinue ADHD medication. “I might suggest a trial discontinuation if someone has been symptom-free for several months,” says Wilens. “What you want to know is whether the medication has been responsible for all the improvement, or if the disorder itself is better.”

ADHD is a chronic, and often lifelong, neurological disorder, but sometimes it does seem to go away. Recent studies suggest that many children with ADHD outgrow aspects of the disorder before reaching adulthood. What’s going on?

Scientists now know that the brain is a “work in progress” until well past puberty. Some researchers theorize that this decades-long maturation process gradually repairs the errant brain circuitry associated with ADHD. Others attribute improvement to the gradual acquisition of coping skills. If ADHD symptoms are mild, and coping skills have indeed been burnished over a number of years, says Wilens, medication may become unnecessary.

A desire to go drug-free can sometimes be triggered by a positive change in life circumstances —  marrying someone who is willing to help with organizational tasks, for example, or switching from a desk job to one that involves lots of physical activity. More commonly, though, the reason people drop drugs is that things in their lives, or with the medications themselves, are not

Susan Brillhart, 42, a pediatric nurse practitioner in Hoboken, New Jersey, was diagnosed with ADHD at age six and medicated until age 16. “It stopped working,” she says. “I realized my medication wasn’t having much effect any more, because my grades were going down.” All that was left, she says, were side effects.

Even in cases where medication still works, side effects can become unbearable. “I’ve gone off medications a number of times,” says Robert Jergen, Ph.D., 36, associate professor of special education at the University of Wisconsin in Oshkosh. “Some drugs caused intense intestinal pains. Some made my heart race. One was effective at reducing my hyperactivity, but I couldn’t sleep. The last medication I was on made it difficult to achieve and maintain erections, and caused vocal tics.”

Other motives for going off medication are even more pragmatic, says Harold Meyer, a therapist and ADHD coach, who heads the New York City chapter of Children and Adults with Attention Deficit Disorder. Meyer has had clients who wanted to discontinue medication because they were starting a job that required drug screening, or planned to enter the armed forces. “I had one client, a private detective, who needed to renew his gun permit. He knew that he’d be asked if he was taking stimulants or other drugs,” says Meyer.

An important caution: Although drugs commonly prescribed for ADHD have not been linked to birth defects, women (and men) who are trying to have children are generally advised to avoid medication.

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