Eli Lilly declared on September 28, 2005 that they are adding a black-box warning to its attention deficit (AD) medication Strattera. The new warning will claim that the drug increase suicidal thoughts among youths. The FDA issued a health advisory on Strattera after evaluating clinical trial data submitted by Eli Lilly. This FDA’s finding prompted Eli Lilly to update Straterra’s label.
FDA officials said Eli Lilly must also have to create a medication guide for patients and health care providers pertaining to the new black box warning. Black box warnings are the most prominent of medication warnings. Dr. Thomas Laughren, director of the FDA’s division of psychiatry products, said in December the federal government requested Lilly to assess 13 clinical trials conducted on children to measure a suicide risk.
The risk for any individual patient taking this drug is quite low, but from a public health standpoint, four (case) per thousand is a fairly big signal, given there are tens of thousands of patients taking this drug,” Laughren said. The FDA said Lilly submitted results from a Strattera clinical trial of 1,357 youths taking the medication that found five of them had increased suicidal thoughts, while none of 851 youths taking a placebo showed such changes. Lilly said one youth attempted suicide during its Strattera trials, but that researchers saw no signs of increased suicidal thoughts among adults.
Strattera (Generic: Atomoxetine hci), Eli Lilly’s popular drug to treat attention deficit disorder (ADD), has been linked to liver problems. Recently, Eli Lilly warned doctors to stop prescribing Strattera in patients with jaundice or who show signs of liver damage. Eli Lilly warned that Strattera can cause severe drug related liver injury that can progress to acute liver failure resulting in death or the need for a liver transplant. In December 2004 the FDA updated Strattera’s label to include the serious liver side effects.
Strattera is the only non-stimulant medication approved by the FDA for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. Strattera is a norepinephrine reuptake inhibitor, a class of ADHD treatment that works differently from the other ADHD medications available. Strattera has been prescribed to over 2 million patients since it was approved in 2002.
In June 2005, the FDA announced it will be investigating all attention deficit hyperactivity disorder drugs including Strattera, Ritalin, Concerta, and Adderall in response to reports of serious psychiatric side effects in patients taking Concerta and Ritalin. Some ADHD drugs are also associated with cardiovascular side effects.
On January 3, 2006, the Food and Drug Administration asked its standing committee of risk-management advisers to review reports of heart-related complications in children and adults using attention deficit disorder drugs. U.S. and Canadian regulators have been looking in the past few years at the probable heart risk of attention-deficit drugs, which are stimulants used to improve concentration.
An approximate 2 million patients, both adults and children have been prescribed Strattera since it was granted FDA approval.
Legal Help For Victims Affected By Strattera
If you or a loved one took Strattera and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).