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FDA Demands New Warnings for ADHD Drugs

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FDA requires new ADHD warning labels. Added warnings advised on ADHD drugs.

An FDA advisory panel voted on Thursday to recommend the most serious type of warning labels for drugs treating attention deficit hyperactivity disorder. The new warning will include cautionary language of those medications causing psychiatric and heart problems, including death.

Approximately 3.3 million children and 1.5 million adults take ADHD drugs, with sales exceeding 3.5 billion dollars annually. In recent years the number of adults using ADHD drugs has dramatically increased, as has the potential risk of cardiovascular problems, including heart attacks and strokes. “Because adults have a higher risk of heart disease and stroke to begin with, any increase in risk caused by these drugs could affect a large number of people,” said Dr. David Graham, an FDA advisor.

The FDA reported 25 deaths associated with the use of ADHD drugs between 1999 and 2003. Nineteen of them were children. The report also described 54 cases of serious cardiovascular problems including heart attack, stroke, hypertension, palpitations and arrhythmia in adults and children. The Centers for Disease Control and Prevention reported that more than 2,500 children taking ADHD drugs went to emergency rooms in 2004, with one-quarter of them experiencing serious heart or blood pressure problems.

Two of the most common ADHD drugs are Adderall made by Shire Pharmaceuticals and Ritalin made by Novartis Pharmaceuticals Corporation. There are a number of other companies which make generic versions of Ritalin which will all have to place new warnings on their ADHD medications.