Cardiology Internal Medicine Blog

Saturday, August 26, 2006

FDA calls for strong warning labels on ADHD Drugs about cardiovascular side effects

Food and Drug Administration (FDA) says that drugs used for ADHD (Attention Deficit Hyperactivity Disorder) must carry warning labels that state that these drugs may cause suppression of growth, psychosis, aggression and serious cardiovascular side effects

In February, an FDA advisory committee had strongly recommended that the FDA require all ADHD drugs come with a black box warning, linking the drugs to serious side cardiovascular side effects. In March, a different committee was convened which recommended additional warnings about psychological side effects.

The warnings state in part, "Sudden deaths, strokes and myocardial infaction have been reported in adults taking stimulant drugs at usual doses." These warnings caution about an increased risk of strokes and heart attacks that come after scattered reports of children dropping dead suddenly while taking the drugs.

"It's appropriately worded," says Steven Nissen, president of the American College of Cardiology and chairman of cardiology at the Cleveland Clinic regarding the warnings. He says, "It basically lets physicians and patients know that these drugs to have serious cardiovascular side effects."

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