FDA to ADHD Drug Makers: Warn Patients

Ivanhoe Newswire
Friday, February 23, 2007; 12:00 AM

By Vivian Richardson, Ivanhoe Health Correspondent

ORLANDO, Fla. (Ivanhoe Newswire) -- Patients need to know about the possible risks associated with medications for attention deficit hyperactivity disorder (ADHD), Food and Drug Administration officials announced this week.

ADHD medications, like Adderall and Ritalin, have been linked in rare cases to cardiovascular risks and some psychiatric symptoms, like hallucinations and paranoia. The FDA is requiring ADHD drug manufacturers to prepare Patient Medication Guides to be handed out when the medications are given to patients. The FDA-approved guides will contain information about the risks and what patients can do to prevent serious problems from happening.

Massachusetts psychiatrist Dennis Rosen, M.D., told Ivanhoe he agrees with the FDA's recent decision. "What it speaks to is the need for all physicians to receive information from the pharmaceutical industry and to provide information to their patients to educate them," he said.

Dr. Rosen said stronger actions, like the "black box" warning an FDA panel suggested about a year ago, could undermine the benefits ADHD medications give patients.

"The relative benefits of these medications versus the risks are so dramatically different that a black box warning would sufficiently imbue Tom Cruise and his cohorts the ammunition to interfere and undermine the sense of trust that patients are beginning to develop with physicians about being educated regarding these factors," Dr. Rosen said.

After a close vote last year, an FDA advisory panel voted recommend a "black box" warning, the strongest warning, after learning of the deaths of 25 people, including 19 children, who had taken ADHD medications. There were also reports of stroke and heart attack in adults with cardiovascular risk factors. Additionally, several studies suggested patients on the medications are more likely to experience adverse psychiatric effects than patients taking placebo, though the risk is just one in 1,000.