ADHD Treatments Get Stronger Warnings
Officials for GlaxoSmithKline and Shire on Monday said that the companies have added strengthened warnings about cardiovascular and psychological risks to the labels of their attention deficit hyperactivity disorder medications at the request of FDA, Bloomberg/Boston Globe reports (Bloomberg/Boston Globe, 8/22).
An FDA spokesperson said that the agency in May asked companies to "strengthen the wording in the warnings section with regard to serious cardiovascular events and psychiatric events" linked with ADHD medications. However, she said that FDA decided the "possible cardiovascular and psychiatric risks would be best addressed by new warning language but did not justify a black box" warning as an agency advisory committee recommended in February.
GSK officials on Monday said that the company has added strengthened warnings to the label of Dexedrine. According to the warnings, adults who have taken Dexedrine have experienced sudden death, stroke and heart attacks, and reports have linked the medication with cases of sudden death among children with heart problems.
The warnings recommend that physicians, before they prescribe Dexedrine, should determine whether patients have family histories of heart problems and perform physical examinations for symptoms of such problems. In addition, according to the warnings, "psychotic or manic symptoms, e.g., hallucinations, delusional thinking or mania in children and adolescents without a prior history" of such problems "can be caused by stimulants at usual doses" in rare cases.
The labels of Adderall, manufactured by Shire, and Concerta, manufactured by Johnson & Johnson, include similar warnings.
All other companies have responded to the request from FDA, and their "responses are currently under review," the agency spokesperson said (Wilde Mathews, Wall Street Journal, 8/22).
Robert Temple, director of the FDA Office of Medical Policy, said, "We're not trying to scare people out of using these drugs. Still, I would be extremely reluctant to put people with heart failure on one of these drugs." Temple added that FDA has begun to consider proposals for studies of the long-term effects of ADHD medications on the heart.
Steven Nissen, chair of the cardiology department at the Cleveland Clinic and a member of the FDA advisory committee that recommended black box warnings for ADHD medications, said, "I think this goes a long way toward properly warning physicians and patients of the potential cardio and psychiatric risks of these drugs" (Harris, New York Times, 8/22).