William O. Cooper, M.D., M.P.H., associate professor of Pediatrics and director of Vanderbilt’s Child and Adolescent Health Research Unit, along with investigators at four other research sites, received a contract from the Agency for Healthcare Research and Quality (AHRQ) to conduct the massive review of records.
Data for the study has been drawn from the insurance records of 10 million U.S. children. Among this group, nearly 300,000 children have been identified as having taken medications used to treat ADHD.
Cooper will lead the medical record review to see if rare cases of sudden cardiac death, heart attack and stroke are somehow related to the medications. ADHD medications are known to increase heart rate and blood pressure. But it is not known whether these side effects directly, or even indirectly, might cause children to suffer heart attack or stroke.
“The FDA had received a series of reports about these events occurring in children with exposure to ADHD medications. However, the events are relatively rare,” Cooper said.
“Because of the ability to identify large populations of persons through large health claim datasets we anticipate being able to pull together a large enough sample from several locations across the country to identify whether a real risk exists,” Cooper said.
“One of the strengths of this work is the ability to build upon the important work in drug safety studies conducted by my collaborators, Dr. Wayne Ray and Dr. Marie Griffin here at Vanderbilt over the past 30 years,” Cooper added.
As principal investigator, Cooper has been contracted by the AHRQ to draw on his own review of TennCare records, and will combine that data with data from three other sites to be analyzed at Vanderbilt. Investigators from each of the sites– which include Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as scientists at AHRQ and the Food and Drug Administration (FDA) — will be collaborating on the research. The study also has an adult component that is being coordinated elsewhere to review similar adult records for the same time period — 1998 to 2005.
The analysis will cover all drugs currently marketed for treating ADHD, including the most popular: Concerta, Adderall and Strattera. These three medications alone are ranked among the top five of all drugs prescribed for children under the age of 17. A recent AHRQ analysis found $1.3 billion was spent on these three drugs in 2004.
In May 2006, based on a review of anecdotal reports of sudden death, stroke and heart attack among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. Drug manufacturers have created Patient Medication Guides for individual products to help patients understand associated risks.
This massive data review will determine whether further labeling changes or some other safety action is needed. The analysis will take two years to complete.
Source: Vanderbilt University