Lilly Adds Warning to Strattera Label

Eli Lilly and Co. on Friday said it added a warning to the label of its attention deficit/hyperactivity disorder medicine, advising patients with jaundice or a liver injury to stop taking the treatment.

Lilly said the label change on the drug, known as Strattera, discusses two reported cases of severe liver injury out of the more than 2 million patients who have taken the medication since approval. Both patients have recovered with normal liver function after discontinuing the medication. The Indianapolis-based company said it is notifying physicians and other health care providers about this label change. Tim Anderson, analyst at Prudential Equity Group who lowered his 2005 earnings forecast for the company, said in a research note Lilly’s move is a “fairly severe label change” and that competitors will use this label change against the product. Lilly’s shares fell $2.00, or 3.48 percent, to $55.40 during afternoon trade on the New York Stock Exchange. The American Stock Exchange’s Pharmaceutical Index fell 4 percent, pulled by Lilly’s decline and a 14 percent drop in Pfizer Inc.’s share price after a clinical trial showed increased risk of heart attack for its arthritis drug, Celebrex. Lilly said it reported the cases of liver injury to the Food and Drug Administration and reviewed all available data on Strattera, which indicated that the benefit-risk profile remains positive. Attention deficit/hyperactivity disorder (ADHD) affects 3 percent to 5 percent of school age children, or about 2 million, the National Institute of Mental Health said on its Web site. The principal characteristics are inattention, hyperactivity and impulsiveness, said the leading federal agency for researching mental and behavioral disorders. Strattera was given during clinical trials to 6,000 patients, who experienced no sign of liver injury, Lilly said. Liver complications are rare with medications, but they occur in a variety of prescription and over-the-counter medicines, the company said. Patients should contact their doctor if they develop pruritus (itchy skin), jaundice, dark urine, upper right-sided abdominal tenderness, or unexplained flu-like symptoms.(Source: Reuters Health: December 2004.)