Cardiovascular Screening and ADHD Meds

ADDitude interviews Steven E. Nissen, M.D., on the FDA’s label advising cardiac screening for those on ADHD medications.

Doctor is ready to test ADHD patients for heart problems
Doctor is ready to test ADHD patients for heart problems

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 ADHD 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 ADHD.

But statistics indicate that the number of cardiac deaths among those who take ADHD 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.

What can someone who is considering taking a stimulant medication or giving it to a child do to minimize the risk?
Before taking any medication for ADHD, make sure the diagnosis is well-established, and that it has been documented by a psychiatrist or a mental-health professional. I advise trying treatments, such as behavioral therapy, before turning to medication.

If medication is needed to manage the impulsivity, distractibility, and hyperactivity of ADHD, the patient should first undergo a thorough examination, including being checked for cardiovascular disease. At a minimum, the doctor should listen to the heart and lungs, and take a complete history. If the prescribing physician detects a heart murmur or high blood pressure, this finding should be investigated before starting an ADHD drug.

Once therapy is started, the clinical response – improved attention – should be monitored and dosage adjusted to achieve the desired effect with the smallest possible dosage. You should monitor for elevated blood pressure and other side effects. I also think it’s a good idea to periodically try going off the medication.

What about people who are already taking a stimulant and who don’t seem to have any problems? Should they take any precautions?
Yes. The effects of increased blood pressure and heart rate are cumulative. The longer you have been taking these medications, the more important it is to be screened periodically.

Are certain individuals who use stimulants more vulnerable to cardiovascular problems?
Yes. Several of the children who experienced sudden death had an underlying disorder known as hypertrophic obstructive cardiomyopathy. This is a heritable disorder that causes increased thickness of the heart muscle. Most patients with this condition have a heart murmur.

Are there diagnostic tests that can predict cardiac risks before they occur?
It’s difficult to justify the cost of such tests for millions of ADHD patients. If a heart murmur is detected, an echocardiogram may be recommended. If an abnormal heart rhythm is found during examination, an EKG might be sensible.

I will say that, the older the adult, the more thorough the evaluation should be. This might include an exercise stress test, but without good data, I can’t recommend that for everyone, either.

What research is needed?
Large, long-term clinical trials. The defense of stimulant medication for treating ADHD is based on studies that involved a few hundred kids.

Are you advising that the FDA ban stimulants?
Of course not. A 12-year-old who is not able to focus at school should certainly be able to get medication that helps him. It’s a matter of balancing risks and benefits. If a medication is potentially risky, we should restrict its use to those for whom it is essential.

I want doctors to think carefully each time they pick up their pen to write a prescription for a stimulant.