There have been 4 drug regulatory agency warnings on Metadate from the United States. These are as follows:
United States, June 15, 2009: The FDA reported on a study reviewing 564 healthy children taking stimulants who died suddenly. They notified the public that there might be an association between the use of stimulant medications (including Metadate) and sudden death in healthy children. Source: “Stimulant Medications Used in Children with Attention-Deficit/Hyperactivity Disorder – Communication about an Ongoing Safety Review,” Food and Drug Administration, June 15, 2009.
United States, February 21, 2007: The FDA directed ADHD drug manufacturers to distribute “patient friendly” guides to consumers warning about serious psychiatric and cardiovascular problems, including stroke, heart attack, sudden death and psychotic reactions caused by ADHD drugs (including Metadate). Source: “FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events,” FDA News, February 21, 2007.
United States, February 09, 2006: The FDA’s Drug Safety and Risk Management Advisory Committee urged that the strongest “black box” warning be issued for ADHD stimulants (including Metadate) because of the risk of heart attacks, strokes and sudden deaths. Dr. Steven Nissen, a cardiologist and member of the advisory committee called this a “potential public health crisis.” The FDA said it had received reports of about 25 deaths linked to the drugs and a larger number of cases involving serious consequences, such as heart attacks. Source: “Warning Urged for ADHD Drugs” LATimes.com, February 10, 2006.
United States, October 1995: The U.S. Drug Enforcement Administration (DEA) said Methylphenidate use (such as the drug Metadate) could lead to addiction and that “psychotic episodes, violent behavior and bizarre mannerisms had been reported” with its abuse. Source: “Methylphenidate,” U.S. Drug Enforcement Administration (DEA), October 1995.
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