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news.An FDA advisory committee has voted to recommend that all stimulant ADHD drugs should come with a "black box" warning to indicate that the drugs may increase the risk of serious cardiovascular problems.
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The committee voted eight to seven in favor of adding the warning to ADHD medications despite recognizing that the data suggests that incidence rates of rare serious cardiovascular adverse events are generally within the rates that would be expected from the untreated general population.
Shire Pharmaceuticals, a leading developer of ADHD medications, released a statement in response to the news saying that it “believes that the interests of physicians and patients would be better served by further study to determine whether there is, in fact, a relationship between these medicines and cardiovascular events.”
“Obtaining this information is crucial prior to taking what would be an unprecedented action to include something in a black box that is not been supported by sufficient data,” continued the statement.