March 24, 2006
FDA panels weigh in on ADHD drugs
This week brought mixed news for ADHD drugs, as federal advisers voted against approving Cephalon’s proposed entrant and another panel saying class labels don’t need black-box warnings for cardiac risk. The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12-1 against recommending agency approval of Sparlon (modafinil), Cepahlon’s investigational compound for ADHD in children and adolescents. The committee citied a need for additional studies to assess the risk the drug could cause a potentially fatal skin rash called Stevens-Johnson Syndrome. Sparlon is sold as Provigil for sleep disorders, and FDA’s postmarketing database turned up three reports of the rash among adults, according to The Wall Street Journal. Meanwhile, the pediatric drugs advisory committee to the FDA said that patients and doctors should be made aware of potential psychosis, aggression and cardiac effects in young people taking ADHD drugs, which include Shire’s Adderall, Novartis’ Ritalin, J&J’s Concerta and Eli Lilly’s Straterra. Data from controls and from the FDA’s adverse event reporting system suggested a need to communicate the events seen during treatment with the drugs, but the panel “did not feel that that rose to the level of a black box,” said Robert Nelson, M.D., committee chair and a physician at Children’s Hospital of Philadelphia. Among the issues it felt need to be highlighted, the panel only called for warning language about cardiac risks in young people with pre-existing heart problems, and that concern is already being added to the labels of most ADHD drugs. Last month an FDA advisory committee voted 8-7 to recommend a black-box warning against cardiovascular risks. The FDA will consider both panels’ recommendations before making a final labeling decision. Nelson added that the FDA’s plan, announced in January, to include a half-page highlights box at the top of all drug labels mitigates the need for a black-box warning. The highlights section “serves the same informational purpose as the black box used to serve,” he said, as contraindications, precautions and warnings will appear at the beginning of the label.