FDA, AHRQ Collaborate to Study ADHD Medication and Heart Problems

The United States Food and Drug Administration announced today that they will collaborate with the Agency for Healthcare Research and Quality in a study aimed to examine the long-term effects on ADHD medications on children and adults. Specifically, the study is aimed to determine if ADHD medications lead to heart problems, such as heart attack or stroke.

It is known that medication to treat Attention Deficit-Hyperactivity Disorder raise blood pressure and heart rate. For these reasons, there are concerns about whether these medications increase the risk of developing cardiovascular problems, such as stroke and heart attack. According to the Food and Drug Administration (FDA) it is also believed that the risks for adults and children may differ, but more research needs to support such a claim.

The FDA and the Agency for Healthcare Research and Quality (AHRQ) plan to do analyses on data collected in a preliminary study already conducted by the FDA. The FDA collected data about outpatient and inpatient care, prescription drug use, and health care outcomes including death, from large databases. Researchers were able to collect information about individuals with ADHD with this technique over a seven year period.

The FDA and the AHRQ plan to analyze the healthcare data of nearly 500,000 individuals with ADHD. Individuals with ADHD often have trouble focusing on schoolwork, work tasks, and play activities, have trouble organizing activities, loses things often, is forgetful in regards to daily activities, does not follow directions often, does not appear to be listening when spoken to, do not like engaging in activities that require a lot of mental effort for an extended period of time, and are easily distracted.

According to the FDA, researchers from Vanderbilt University, HMO Research Network and 13 Drug Safety, Kaiser Permanente, the AHRQ, and the FDA will be analyzing the data. All ADHD medications will be analyzed; the risk of developing heart-related problems will be analyzed according to ADHD medications as a whole as well as specific classes of ADHD medications.

The analysis is expected to take about two years, according to the FDA. The results are expected not only to impact the doctors, patients, and families of those who are currently taking ADHD medications, but also to Medicare, Medicaid, and to government insurance programs asserts the FDA.

Having better information regarding the risk of heart problem development as a result of ADHD medications will help patients and doctors more effectively weigh the risks and benefits of taking medication to treat ADHD for each patient's particular situation.

For more information on ADHD, visit the National Institute of Mental Health's page on ADHD at: http://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd/index.shtml.

Source:

Food and Drug Administration News:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01700.html