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AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks with ADHD Medications

Tuesday, September 18, 2007 General News J E 4
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ROCKVILLE, Md., Sept. 17 Two U.S. Department ofHealth and Human Services agencies will collaborate in the most comprehensivestudy to date of prescription medications used to treat attention deficithyperactivity disorder (ADHD) and the potential for increased risk of heartattack, stroke or other cardiovascular problems.

Researchers supported by the Agency for Healthcare Research and Qualityand the U.S. Food and Drug Administration will examine the clinical data ofabout 500,000 children and adults who have taken medications used to treatADHD to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and bloodpressure, there are concerns about the drugs' potential to increase cardiacrisks. It is also thought these risks may be different for adults andchildren, but more evidence is needed about the long-term effects of usingADHD medications.

The planned analysis follows an FDA-sponsored preliminary study thatcompiled information from large health care databases on prescription druguse, inpatient care, outpatient treatment, and health outcomes, includingdeath. Based on that effort, researchers identified people who took ADHD drugsduring a 7-year period ending in 2005. AHRQ, which sponsors research onclinical effectiveness and safety, will team with FDA to complete the analysisof the data.

"This study highlights one of AHRQ's most important missions: to collectand analyze scientific evidence that will help patients, policymakers, andclinicians make the best possible decisions," said AHRQ Director Carolyn M.Clancy, M.D. "This partnership with the FDA is a great way to move closer toanswering important clinical questions that affect children and adults whohave ADHD."

"Case reports have described adverse cardiovascular events in adult andpediatric patients with certain underlying risk factors who receive drugtreatment for ADHD, but it is unknown whether or not these events are causallyrelated to treatment," said Gerald Dal Pan, M.D., director of FDA's Office ofSurveillance and Epidemiology. "The goal of this study is to develop betterinformation on this question."

The study will be coordinated by Vanderbilt University researchers oncontract through AHRQ's Effective Health Care program. Data analysis will beperformed by researchers at Vanderbilt, Kaiser Permanente of California, theHMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. Theanalysis will include all drugs currently marketed for treating ADHD. Thestudy will analyze the risks of all the drugs as a whole, and risks of thedrugs grouped by class.

The analysis will take about 2 two years to complete. Results are expectedto be important not only to patients, their families and health careproviders, but also to government insurance programs. Medicaid, Medicare, andthe State Children's Health Insurance Program provide reimbursement for drugsprescribed for ADHD. This information could also be used to inform productlabeling, which is used by health care providers when making treatmentdecisions.

ADHD is a behavioral disorder that, in many patients, causeshyperactivity, and may have a significant impact on school performance andsocial functioning. According to the National Institute of Mental Health, ADHDaffects approximately 3 percent to 5 percent of school-age children and about4 percent of adults.

Use of ADHD drugs has increased in recent years among children and adults.A recent AHRQ analysis of medication expenditures found three ADHD drugs-Concerta, Strattera, and Adderall-ranked among the top five drugs prescribedfor children ages 17 years and younger. About $1.3 billion was spent on thosedrugs in 2004, the study estimated. Adult use is also believed to beincreasing.

In May 2006, based on a review of anecdotal reports of heart attack,stroke and su
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