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Home Wellness Research ADD, ADHD, and other Psychological Disorders FDA Changes Label Rules on ADHD Stimulants

FDA Changes Label Rules on ADHD Stimulants

Wednesday, 22 October 2008 15:07

On June 29, 2005 the Wall Street Journal Online published a remarkable article by Jennifer Corbett Dooren titled "FDA Wants Label Changes For Some ADHD Drugs."  Here is the article

In the article, Dooren notes that the FDA is requiring new labeling changes for stimulant drugs used to treat ADHD. Most, it appears, are variations on methylphenidate (Ritalin, Concerta, etc.). The drugs have produced side-effects including, according to the FDA, events "such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior."

The article adds: "Meanwhile, the FDA is seeking the panel's advice on what information it should provide to the public about the ADHD drugs that are widely used in children while it's collecting information on the number of types of psychiatric events possibly associated with ADHD drugs along with possible cardiovascular risks.

"The agency is concerned with possible cardiovascular events in people using the drugs. Earlier this year Health Canada ordered Adderall off the market after reports of sudden death in 20 patients, including 12 reports of stroke."

While these drugs clearly help some severely afflicted individuals, they also are increasingly being found to have adverse effects. At the same time some are being implicated as possible causes for liver cancer, scientists report that incidents of liver cancer in children have roughly doubled over the past two decades.