Experts Urge Stern ADHD Drug Warnings

Feb. 9, 2006 -- In a surprise move, an advisory panel urged the FDA to place strong warnings on all stimulant drugs used to treat attention deficit hyperactivity disorder (ADHD) because of a potential risk of heart attacks, strokes, and sudden death.

The experts voted unanimously, with one abstention, to recommend that FDA include "medication guides" with all stimulant ADHD drugs -- Adderall, Concerta, and Ritalin -- warning patients about the potential heart risks.

The panel also voted 8 to 7, with one abstention, to urge the FDA to place strong "black box" warnings on all of the drugs' labels and advertisements. The warning should alert doctors and patients the drugs increase heart rate and blood pressure, and that researchers are unsure about the real-world consequences of those changes, some panelists said.

As with all recommended warnings, patients and parents should first consult with a doctor before making any treatment decisions.

Unusual Move

Committees sometimes recommend such warnings for drugs believed to carry dangerous side effects. But Thursday's move was highly unusual because the panel was convened to advise the FDA on how to design studies looking at potential health risks with ADHD stimulant drugs.

Instead, several experts expressed strong concerns that stimulant drugs like Adderall and Ritalin were being overprescribed -- particularly to adults -- and that the public and doctors were largely unaware of potential risks. A number moved that the panel step outside its agenda and vote on stronger warnings for the drugs.

"I think the only way we're going to get the attention of the medical community and the pharmacy community ... is through the black box warning," said Henri R. Mannasse Jr., PhD, CEO of the American System of Health System Pharmacists and a member of the panel.

The FDA does not have to follow the committee's recommendation. Officials appeared to be caught off-guard by the committee's action.

FDA Reluctant

Officials said they would be reluctant to place a black box warning on the drugs' labels based on a theoretical risk. Such warnings could deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research.

"The absence of bona fide problems in your hand pushes against the box," Temple said. "We will also, frankly, worry about the possibility that overstatement can do active harm."

Temple said the agency would wait for the advice of a pediatric advisory committee in March before reaching a decision on new warnings. That panel consists of pediatricians and psychiatrists who are more likely to look favorably on the benefits of ADHD treatment.

Preliminary Study of Risks

The recommendation came after FDA scientists presented a preliminary study implicating stimulant drugs with a possible increased risk of heart attacks and strokes.