Warning Added to ADHD Drug

Pharmacy Times, Volume 0, 0

Eli Lilly and Co is taking swift actionto notify pharmacists, physicians, andpatients regarding the warning added toits drug Strattera. The drug is indicatedfor the treatment of attentiondeficit/hyperactivity disorder (ADHD)in children, adolescents, and adults. Thewarning indicates that the medicationshould be stopped in patients with jaundiceor laboratory evidence of liverinjury. The revised label discusses 2reported cases of severe liver injury outof >2 million patients who have takenthe medication since its approval. Thepatients who experienced the liver problemshave had normal liver functionsince discontinuing the medication.

Lilly has been notifying physicians,other health care providers, and consumeradvocacy and professionallyfocused associations regarding the labelchange so that they have the tools toprovide important information topatients. Lilly's outreach efforts includea "Dear Healthcare Professional" letter,sales force communication to prescribers,and information on Strattera'sWeb site (www.strattera.com). "Patientsafety is our top priority at Lilly," saidDouglas Kelsey, MD, a pediatrician anda clinical research physician at Eli Lillyand Co, in a press statement.