Safety of ADHD Medications Called into Question

For a small group of children and adults with ADHD, ADHD medications can have serious side-effects.

Just how safe are ADHD drugs?

In early 2006, two FDA advisory committees met to discuss health risks associated with ADHD (attention deficit hyperactivity disorder) medications.

One FDA review of data concerning serious cardiovascular adverse events in patients taking usual doses of ADHD medications 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.

In the end, the pediatric panel cited evidence from clinical trial studies that the incidence of psychiatric events was very small. The panelists also explained that most reports of cardiovascular events were associated with other risk factors, such as underlying heart disease or heart defects.

The FDA recommended that children, adolescents, or adults who are being considered for treatment with ADHD drugs 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).

Are ADHD medications safe for your child?

Dr. William Barbaresi, chairman of the Division of Developmental and Behavioral Pediatrics and a co-director of the Mayo Clinic Dana Child Development and Learning Disorders Program says that ADHD drugs are safe.

"ADHD medications have been prescribed longer than most every other class of medications currently available," says Barbaresi. "There's more research literature available on ADHD medications than on a large percentage of medications currently prescribed within the United States. As long as physicians follow appropriate guidelines and monitor patients for side effects, ADHD medications should be considered safe."

As for effectiveness, Barbaresi says "stimulants — which are the medications most frequently prescribed for ADHD — not only help children with ADHD in the short term but also are effective in the long run. For example, treatment with stimulants is associated with decreased risk of development of substance abuse disorders and decreased emergency room utilization."

The ADHD medicines that were the focus of the revised labeling and new Patient Medication Guides ordered by the FDA include the following 15 ADHD drugs:

• 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

Sources:

• FDA
• William Barbaresi, M.D., developmental and behavioral pediatrician at Mayo Clinic

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