Metadate Black Box Warning Recommended. On February 9, 2006, an FDA panel voted to recommend a black box warning for Metadate and other drugs prescribed to treat attention deficit hyperactivity disorder (ADHD or ADD). The Food and Drug Administration scientific committee voted 8-7 to add a black box warning, the agency’s strongest, to the labels of five drugs in the class including Metadate, Methylin, Ritalin, Concerta and Adderall.
Deaths Reported to the FDA
The FDA had requested a review by the panel to evaluate ways of studying the ADHD drugs because of its data suggesting a link between the drugs and the risk of sudden death and serious cardiovascular problems including heart attacks, stroke, hypertension, palpitations and arrhythmia. The agency reported 25 deaths between 1999 and 2003 which may be related to the ADHD drugs included in the warning. Nineteen of the 25 deaths were children. There were 54 cases of serious cardiovascular problems reported in children and adults.
Metadate CD is a reformulation of Ritalin for extended delivery over several hours.It comes in 10 and 20 mg tablets and delivers a small, steady dose throughout the day. The active ingredient, methylphenidate, is reported to have serious cardiovascular side effects including cardiac arrhythmia, tachycardia, chest pain and hypertension. Reported psychiatric side effects of methylphenidate include suicidal thoughts, aggression, psychotic behavior and hallucinations.