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New Guides for ADHD Meds

Ritalin

The identification of medical and mental health risks from use of medications to treat Attention Deficit Hyperactivity Disorder (ADHD) has stimulated the U.S. Food and Drug Administration (FDA) to instruct manufactures to develop Patient Medication Guides.

Patient Medication Guides alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and inform patients on precautions that can be taken.

“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER).

“In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns.”

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

  • Adderall (mixed salts of a single entity amphetamine product) Tablets
  • Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
  • Concerta (methylphenidate hydrochloride) Extended-Release Tablets
  • Daytrana (methylphenidate) Transdermal System
  • Desoxyn (methamphetamine HCl) Tablets
  • Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
  • Focalin (dexmethylphenidate hydrochloride) Tablets
  • Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
  • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
  • Methylin (methylphenidate hydrochloride) Oral Solution and Chewable Tablets
  • Ritalin (methylphenidate hydrochloride) Tablets
  • Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
  • Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
  • Strattera (atomoxetine HCl) Capsules

The draft Patient Medication Guides for each product can be found at http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm283449.htm.

Source: U.S. Food and Drug Administration

New Guides for ADHD Meds

Rick Nauert PhD

Rick Nauert, PhDDr. Rick Nauert has over 25 years experience in clinical, administrative and academic healthcare. He is currently an associate professor for Rocky Mountain University of Health Professionals doctoral program in health promotion and wellness. Dr. Nauert began his career as a clinical physical therapist and served as a regional manager for a publicly traded multidisciplinary rehabilitation agency for 12 years. He has masters degrees in health-fitness management and healthcare administration and a doctoral degree from The University of Texas at Austin focused on health care informatics, health administration, health education and health policy. His research efforts included the area of telehealth with a specialty in disease management.

APA Reference
Nauert PhD, R. (2016). New Guides for ADHD Meds. Psych Central. Retrieved on August 16, 2018, from https://psychcentral.com/news/2007/02/22/new-guides-for-adhd-meds/642.html

 

Scientifically Reviewed
Last updated: 27 Jun 2016
Last reviewed: By John M. Grohol, Psy.D. on 27 Jun 2016
Published on PsychCentral.com. All rights reserved.