Are ADHD drugs really safe and effective? Find out what the USDA is urging patients to consider.

The U.S. Food and Drug Administration (FDA) has directed the manufacturers of all drugs approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides. These Guides must alert patients that possible cardiovascular risks and adverse mental symptoms are associated with the medicines. The Guides are intended to advise them of precautions.

Serious Side Effects

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. It also shows reports of both 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. These include hearing voices, becoming suspicious for no reason, and also becoming manic. These events occur even in patients who also did not have previous psychiatric problems.

ADHD Patients

ADHD is an alleged condition that is said to affect 3 to 7 percent of school-aged children. It also affects approximately 4 percent of adults. There is no scientific research actually proving the existence of ADHD as an actual disease or condition. The three main symptoms are inattention, hyperactivity, and also impulsivity. People labeled as suffering from ADHD may have difficulty in school, troubled relationships and also low self-esteem.

Contraindicated Medications

In May 2006, the FDA directed manufacturers of the following drugs to revise product labeling for doctors. This reflects concerns about both adverse cardiovascular and psychiatric events. These changes were based on recommendations from both the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

The medicines that are the focus of the directive include the following 15 products:

  • Adderall (mixed salts of a single-entity amphetamine product) Tablets, also
  • Adderall XR (mixed salts of a single-entity amphetamine product) 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, also
  • Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
  • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
  • Methylin (methylphenidate hydrochloride) Oral Solution, also
  • Methylin (methylphenidate hydrochloride) Chewable Tablets
  • Ritalin (methylphenidate hydrochloride) Tablets, also
  • Ritalin-SR (methylphenidate hydrochloride) Sustained-Release Tablets, also
  • Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
  • Strattera (atomoxetine HCl) Capsules

SOURCE: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

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