Cardiovascular and psychiatric adverse events linked to ADHD agents


The FDA ( Food and Drug Administration ) directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder ( ADHD ) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

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.

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

· Methylin ( Methylphenidate hydrochloride ) Chewable Tablets

· Ritalin ( Methylphenidate hydrochloride ) Tablets

· Ritalin SR ( Methylphenidate hydrochloride ) Sustained-Release Tablets

· Ritalin LA ( Methylphenidate hydrochloride ) Extended-Release Capsules

· Strattera ( Atomoxetine HCl ) Capsules


Source: FDA, 2007


XagenaMedicine_2007



Indietro

Altri articoli

Given the rapidly increasing use of stimulant medications during pregnancy and among women of reproductive age who may become pregnant...


The FDA ( Food and Drug Administration ) has warned that Methylphenidate products, one type of stimulant drug used to...


Adults with attention-deficit / hyperactivity disorder ( ADHD ) show a blunted response to the Methylphenidate ( Ritalin ), which...


A study has assessed the effectiveness of Phenylephrine, the active ingredient in products such as Actifed, Sudafed PE, and...


Cocaine use during pregnancy can cause subtle but disabling cognitive impairments -- attention deficits, learning disabilities and emotional problems. A...


A fifth of young adults whose blood vessels ruptured inside their brain abused drugs and more than 40 percent had...


Researchers at University of Toronto have discovered a new mechanism for the neurodegenerative effects of amphetamines. These drugs are converted...


A study led by Pastor R. Couceyro, at Rosalind Franklin University of Medicine and Science and colleagues at Amgen sheds...


A research published in the American Journal of Psychiatry indicates that methamphetamine abuse and HIV infection cause significant alterations in...