Strong Warnings for Ritalin and other ADHD Drugs Still Under Debate
March 31st, 2006
An FDA advisory panel debated the issue on whether a “black box” warning should be placed on drugs such as Ritalin, prescribed for hyperactivity and attention deficit disorder. Up to 3.3 million Americans under the age of 20 take ADHD medications such as Ritalin, Adderal and Straterra.
Psychiatrists urged the FDA to carefully consider a previous proposal to include the strongest warnings about heart attack, hallucinations and other potential risks. These adverse events believed to be associated with the drugs are seen in only a small numbers of patients.
Mental health advocates emphasized that leaving conditions untreated in children who need these medications could be equally as risky as the potential cardiovascular and psychiatric risks a few might encounter from their use. The likely outcome is that stronger wordings of potential adverse effects will be included, but a black box warning will be avoided.
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