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A major study looking at whether drugs used to treat attention deficit and hyperactivity disorder (ADHD) also cause heart problems is to be conducted by the US Government.
Although medications such as Shire’s Adderall® (mixed amphetamine salts) and Johnson & Johnson’s Concerta® (methylphenidate SR) raise blood pressure, investigators say it is unclear whether this puts patients at risk of heart problems.
The FDA and the US Agency for Healthcare Research and Quality (AHRQ) will now study data from 500,000 children and adults who have taken ADHD drugs for at least seven years.
The results of the study, believed to be the largest on this topic to date, are expected to be announced in 2009.
Last year, the FDA asked US drug companies to include new warnings with their drugs based on reports of heart attacks, strokes and deaths among children and adults treated for ADHD.
Adderall, Concerta and Eli Lilly’s Strattera® (atomoxetine) are among the drugs most frequently prescribed to individuals under 17, according to the US Government.
AHRQ director Carolyn Clancy said: “This study highlights one of AHRQ’s most important missions: to collect and analyse scientific evidence that will help patients, policymakers and clinicians make the best possible decisions.
“This partnership with the FDA is a great way to move closer to answering important clinical questions that affect children and adults who have ADHD.”
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