Drug company investors breathed a sigh of relief Thursday after a group of medical experts said the Food and Drug Administration shouldn't impose a black box warning on treatments for attention deficit hyperactivity disorder. A black box warning is the FDA's strongest alert, and it usually leads to depressed sales for drugs that carry the warning. However, the panel of outside advisers said labels for ADHD drugs should clearly describe their potential for psychiatric and cardiovascular risks. The advisory panel, which met for about 11 hours Wednesday, didn't take a formal vote. The consensus opinion contrasted with a vote last month of another FDA committee. That panel voted 8-7, with one abstention,
to recommend a black box warning about cardiovascular risks for all but one ADHD drug on the market. The FDA isn't bound by its advisory panels' suggestions. The latest committee comprised mostly experts in pediatrics, adolescent medicine and psychiatry. Most advisers at last month's panel specialize in risk management, epidemiology and medical administration. being reviewed today by another FDA panel . Cephalon's stock has been halted pending the panel's vote on the drug designed for children ages 6 to 17. The company with the most to win or lose from the FDA's verdict is Shire PLC ( SHPGY). Shire sells Adderall XR and Adderall, which are prescribed for children and adults. It also has agreements with two other companies for experimental ADHD medications.
A skin patch, developed in collaboration with Noven Pharmaceuticals ( NOVN) is
now under review by the FDA. The agency is expected to act in early April on the product called Daytrana, which would treat children ages 6 to 12. Shire also is working with New River Pharmaceuticals ( NRPH), whose drug NRP104 is meant for children from 6 years old to 12. The FDA began reviewing the drug in January. Adderall XR and Adderall already have a black box warning, alerting doctors and patients to the potential abuse of amphetamines, which could cause heart damage or sudden death. These drugs are stimulants, as are J&J's Concerta, Novartis' Ritalin and generic forms of Ritalin. The Shire-Noven product contains the same ingredient found in Ritalin and Concerta. The Shire-New River compound contains an amphetamine derivative, which, the companies say, has a reduced risk of addiction. Cephalon's Sparlon isn't considered a stimulant. Neither is Lilly's Strattera, a drug on the market since 2003. Strattera carries a black box warning that it could cause suicidal thinking among adolescents and children, as well a strong caution about potential liver damage.
Last year alone, 1.7 million adults age 20 to 64 used ADHD drugs, while 3.3 million children and adolescents took the drugs, Medco says. The consensus among the advisory committee participants Wednesday was that potential psychiatric and cardiovascular risks, though rare, should be made more clear to doctors and patients. During the discussions, panel members heard reports from FDA staff members about some children experiencing hallucinations, such as crawling insects, snakes and worms, while taking ADHD drugs. The hallucinations usually ended when the children stopped taking the drugs.