The Food and Drug Administration has issued a new warning for atomoxetine HCl concerning the potential for severe liver injury. The drug, indicated for the treatment of attention-deficit hyperactivity disorder in adults and children, has been available since 2002.
Two cases of severe liver injury were reported in a teenager and an adult who had taken atomoxetine (Strattera) for several months. Both patients recovered normal liver function after discontinuing the medication.
The revised labeling will state that severe liver injury may progress to liver failure, which can result in death or the need for an organ transplant. It will point out that because of the possible underreporting of adverse events, the actual number of cases of liver injury is unknown, and atomoxetine should be discontinued in patents who have developed jaundice or have laboratory evidence of liver injury.
Eli Lilly & Co., manufacturer of the medication, will issue “Dear Healthcare Provider” letters to alert prescribers to this new warning. “Our thorough review of the clinical trial and real-world data indicate that the benefit-risk profile for Strattera is positive,” Douglas Kelsey, M.D., a pediatrician and clinical research physician with Eli Lilly, said in a written statement.
Patient package inserts will also carry information detailing the signs and symptoms of liver problems.
Reports of any adverse events associated with Strattera can be reported directly to Eli Lilly at 800-LillyRx, or to the FDA's MedWatch program at 800-332-1088. MedWatch forms can be downloaded at http://www.fda.gov/medwatch/safety/3500.pdf