ADHD Drug to Get Stronger Warning due to link to Increased Risk of Heart Disease.

As seen on Health Central

U.S. officials have asked a pharmaceutical company to add a label warning of a risk for heart problems for patients taking the prescription drug Dexedrine, a stimulant used to treat attention-deficit hyperactivity disorder (ADHD).

The warning describes some instances of sudden death in children and teens with structural cardiac abnormalities or other heart problems. It also mentions various potential psychological side effects, including hallucinations or delusional thinking.

The U.S. Food and Drug Administration could not be reached for comment, and it was unclear what other ADHD drugs might be affected by this new warning.

Back in May, the FDA had asked makers of similar stimulant ADHD drugs to add the warnings.

"This had already been done with other stimulants," said Dr. Melvin Oatis, an assistant professor of clinical psychiatry at New York University School of Medicine's Child Study Center. "Dexedrine is in an older class of stimulants, and not much new had been done with that."

A letter sent from Dexedrine's maker, GlaxoSmithKline, to health-care providers was posted Tuesday on the FDA's Web site. The letter detailed the planned changes to prescription recommendations.

In March, an FDA pediatric advisory committee had recommended that ADHD drugs not carry the more severe "black-box" warnings and instead use simpler language and include more information on the labels about the heart risks posed by the drugs. But the month before, a different FDA advisory committee had reached the opposite conclusion, and called for a black-box warning on ADHD drugs because of possible cardiac risks.

The FDA has apparently settled for the less-severe advisory.

"This is not a black-box warning," Oatis said. "There's some association [between Dexedrine and heart problems]. They're not making this a causality."

An estimated 2.5 million American children under the age of 19 take ADHD drugs, as do 1.5 million adults.

This represents a huge surge in use, experts said.

In addition to "serious" cardiovascular side effects, the warnings issued since last spring cite possible suppression of children's growth, as well as heightened risks for psychosis, bipolar illness and aggression.

Oatis added that the new warning "should remind clinicians to review the side-effect profiles of medications. It reminds you to take more of a history of family issues regarding stimulant use and medical cardiac risk."