Stimulant medications, such as methylphenidate and amphetamine (brand names Concerta, Focalin, Ritalin, Adderall, and others), are widely used to treat ADHD, and with good reason: They're highly effective at managing the distractibility, impulsivity, and hyperactivity that are the hallmarks of ADHD.
Stimulants can cause several relatively benign side effects, including anxiety, poor appetite, or sleep problems. Now, the FDA has approved the addition of a label warning that the drugs can also cause cardiovascular problems.
Steven E. Nissen, M.D., who chairs the department of cardiovascular medicine at the Cleveland Clinic in Ohio, is the FDA panel member who championed the stiffer warning. ADDitude sat down with Dr. Nissen to ask why he thinks the new warning label is necessary — and what the ADD community should know about ADHD medications.
Stimulant medications have been widely used for decades. Why raise the alarm now?
In the past few years, there have been 25 confirmed cases of sudden death in children who were taking stimulant drugs for ADD.
But statistics indicate that the number of cardiac deaths among those who take ADD drugs is no higher than among the general population.
Drug safety is monitored with what's called the Adverse Event Reporting System, in which a doctor or consumer informs the FDA of bad reactions to a particular medication. This system is voluntary, and it's likely that many adverse events caused by stimulants go unreported. In fact, every study that has looked at the system has found that only 1 percent to 10 percent of adverse events get reported.
What makes ADHD medications risky for those with cardiac disease?
We know that stimulant medications raise heart rate and blood pressure, neither of which is good for the heart.
Are the stimulants safer for adults than for kids?
No. As you grow older, you become more vulnerable to cardiovascular problems.
Do all the stimulants on the market carry the same risks? Are some safer than others?
There is no comparative data. Therefore, unless it's proven otherwise, we must assume that all drugs in this class carry similar risks.
This article comes from the October/November 2006 issue of ADDitude.