Is ADHD Medication Safe to Use?

By Frederick Walker, DO

This past February a Food and Drug Administration safety advisory panel voted 8 to 7 (with one member absent) to back a recommendation for a black-box warning to be placed on the labels of all stimulant medications used to treat attention-deficit/hyperactivity disorder (ADHD).

Some advisers reported they voted for the warning because they were concerned about the recent increase in the number of prescriptions written for the medications for both children and adults. They admittedly were not particularly worried about health issues relating to the potential of increased risk of heart attack, stroke and sudden death.

During a recent public meeting on February 9, FDA officials told members of the Safety panel that between 1999 and 2003, 78 million prescriptions were written for ADHD medications for individuals under 18, and 14 million were written for adults. In contrast, in the 12-year period from 1992 to 2004, 190 million prescriptions for ADHD medications were written for both children and adults. The F.D.A. safety panel explained their perception of the very rare reports of deaths and serious cardiovascular events the FDA has received. The reported reason for the meeting was to explore how to study possible cause and effect of such a rare event. Unexpectedly the safety panel discussion quickly turned to a recommendation for a new warning on the Stimulants labels which was not something the FDA was ever considering.

A cardiologists consultant to the advisory committee was quoted,I want to cause peoples hands to tremble a little bit before they write that prescription for an ADHD medication. It was the cardiologist who initiated the suggestion to the committee to consider a black-box warning because he felt the need to slow the growth of utilization. The doctor and another committee member proposed they were concerned about the recent increase in prescriptions to adults. They reasoned if the drugs are associated with rare cardiovascular adverse events, the risk in adults would be higher due to the incidence of underlying heart disease being higher in adults.

The American Psychiatric Association (APA) described that view as unsupported by clear evidence at this time. The APA also expressed concerns about the process by which the FDA panel, originally assigned how to study potential cardiovascular events, unexpectedly recommended that the FDA issue new black-box warnings. Furthermore the APA said, The FDA is to be commended for responding to reports about possible increased risk of hypertension, heart attacks, and strokes associated with the use of these medications by embarking on such a detailed study. They emphasized, however, that the FDA panel took action that even some panel members acknowledged was beyond the scope of their mission. The APA said any regulatory actions the FDA takes should be based on scientific evidence and the welfare of patients who currently use the medications. Concerns over the efficacy and safety of medications to treat ADHD, as well as questions about the validity of the disorder itself, have been around for many years. Yet last summer a different FDA advisory panel studied postmarketing adverse-event reports for some ADHD medications and noted what it described as a concerning trend. Most adverse reports involved adults and children with preexisting underlying structural heart disease who suffered sudden cardiac death, presumably due to arrhythmias. Stimulants can increase heart rate as well as blood pressure and could lower the threshold for cardiac arrhythmias as well. Most of the reports involved multiple medications and other possible causes of deaths and so were discounted. The 39 death reports in analysis were not definitively tied to an ADHD medication, but are simply associated. Still, she said, the reports were substantially below background rates that would be expected in the general population.

A Fellow FDA safety panel member reported that the FDA would not have asked the committee to explore the adverse-event reports and methods to study possible associations between ADHD medications and the rare adverse events without some level of concern. A committee member felt consumers have a false sense of security in assuming that stimulants are safe. "For us to sit around and talk about it and for us to not make a very strong warning about the uncertainty of these drugs and their possible risks would be unethical, Yet it was that very uncertainty that underscored FDAs restraint.

We still believe that what you tell people should reflect the available data, even if you are a little more inclined to act in the face of uncertainty, said the FDAs Office of Medical Policy, at a press briefing.

We didnt find the sudden-death data very persuasive. The FDAs office of medical policy added that FDA officials do not usually write black boxes about something that there isnt some evidence for but I dont think weve reached our conclusions about that yet. The director of the Division of Psychiatric Drug Products, said that the FDA will wait until the March 22 meeting of the Pediatric Advisory Committee before moving ahead with any new warnings. That panel of pediatric specialists is going to be enhanced by a number of child psychiatrists, who have a lot more direct experience in dealing with ADHD. We believe it's important for a committee that has some direct knowledge and experience with the condition to also weigh in on this issue.

Dr. Frederick Walker is a native of Louisville and a graduate of the University of Louisville School of Medicine, Department of Psychiatry and Behavioral Sciences. He is a general psychiatrist in private practice here in Louisville. Dr. Walker is currently accepting new patients with immediate appointments available and can be reached at (502) 657-6070.