Methylin Black Box Warning Recommended. On February 9, 2006, an FDA panel voted to recommend a black box warning for Methylin 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 ‘Methylin’, Ritalin, Concerta, Adderall and Metadate.
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.
Methylin contains Methylphenidate (MPH), which is an amphetamine-like stimulant that is found in numerous ADHD drugs. ‘Methylin’, Ritalin, Concerta and Metadate all contain Methylphenidate. Other drugs containing Methylphenidate include Rubifen and Focaline. Methylphenidate is a central nervous system (CNS) stimulant which is thought to have a calming effect on some children with ADHD. It is also thought to reduce impulsive behavior and acting out. It is said to increase concentration in children and adults with ADHD. Adderall contains amphetamines.