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US government to probe ADHD drug risks

The FDA is partnering with the Agency for Healthcare Research and Quality on a large-scale investigation into whether drugs for attention deficit hyperactivity disorder may increase the risk of heart attack, stroke and other cardiovascular conditions

The FDA is partnering with the Agency for Healthcare Research and Quality (AHRQ) on a large-scale investigation into whether drugs for attention deficit hyperactivity disorder (ADHD) may increase the risk of heart attack, stroke and other cardiovascular conditions.

"Case reports have described adverse cardiovascular events in adult and paediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," Gerald Dal Pan, director of FDA's Office of Surveillance and Epidemiology, explained in a prepared statement.

The government researchers will analyse existing data from approximately half a million adult and paediatric patients who have taken ADHD drugs in what will be "the most comprehensive study to date" of the issue, according to the FDA. The data to be studied was mined from large healthcare databases in a previous project sponsored by the FDA. It includes information on people who took ADHD drugs over a seven-year period ending in 2005.

One major goal of the new analysis will be to attempt to determine whether the potential for cardiovascular effects is different in adults and children. The ADHD therapies include Ortho McNeil's Concerta (methylphenidate), Eli Lilly's Strattera (atomoxetine) and Shire's Adderall (amphetamine) are among the top-five drugs prescribed to children in the US, according to the AHRQ.

The study will be coordinated by Vanderbilt University researchers on contract with AHRQ. It will involve a team of scientists from the FDA, AHRQ, Vanderbilt, the health insurer Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety.

AHRQ, formerly known as the Agency for Health Care Policy and Research, is charged with conducting research that helps the public make informed decisions and improves the quality of healthcare services. The HMO Research Network is a consortium of 15 HMO organizations with formal research capabilities, while i3 Drug Safety is a private firm specializing in pharmacoepidemiology and pharmacovigilance.

The effort is expected to take about two years to complete.

Concern about the possible cardiovascular effects of ADHD drugs has been building for some time. In 2006, the FDA responded to anecdotal reports of events including sudden death by asking manufacturers to create new labelling and Medication Guides to alert consumers to the potential cardiovascular risks, as well as to possible adverse psychiatric reactions, such as paranoia and mania.

The label warnings became a lightning rod for personal injury lawyers. A number of attempts to sue pharmaceutical firms for adverse cardiovascular events believed to be related to ADHD medications are already underway, building on a long history of claims against ADHD drug manufacturers that in the past focused largely on alleged psychiatric adverse events.

Along with the Adderall, Concerta and Strattera product lines, marketed ADHD drugs include Novartis' Ritalin and Focalin, as well as Shire's Daytrana, among others.

19th September 2007

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