Strattera (Atomoxetine) and Suicide/Suicidal Ideation in Children
On September 29, 2005 the Food and Drug Administration issued a Public Health Advisory regarding Straterra, a medication commonly prescribed for Attention Deficit Hyperactivity Disorder (ADHD) in children. Over two million children have been treated with this medication to date, and a recent study showed an abnormally high incidence of suicidal ideation in children taking the drug versus no such reports in children taking a placebo.
The FDA press release reads in part:
Today's actions follow a review and analysis of 12 clinical trials conducted in children with ADHD and one trial in children with enuresis (bedwetting) that identified an increased risk of suicidal thinking for Strattera. There was one suicide attempt by a patient who received Strattera among the approximately 2,200 patients in the trial. As part of a larger evaluation of psychiatric drugs and suicidality, FDA had requested that the manufacturer conduct a review of its database and clinical trials, which included more than 2200 patients--1350 patients receiving Strattera (atomoxetine) and 851 receiving a placebo. The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo.
Strattera, manufactured by Eli Lilly, has been on the market since 2002 and has been used in more than two million patients.
The mathematics here are simple. 2 million children treated versus a 0.4% incidence equals 8000 cases, of which some had to have resulted in suicide attempts with non-fatal and even fatal outcomes. In fact, it appears that a strong case can be made for personal injury to any child who exhibited suicidal behavior while being treated with Strattera, with or without fatal outcomes.
Strattera's new black label warning is the highest level of advisory warning the FDA issues without outright banning a medication. If it is publicized among the members of the community directly affected by ADHD, which is highly probable, the chances are high that numerous new reports will be made to Physicians who will report the incidents to the FDA Medwatch service. The incidence of this side effect, until now not associated with the concurrent use of Strattera, may in fact significantly exceed the results of the FDA studies as real world post trial marketing takes place naturally. Each .01% higher incidence of suicidal ideation is an additional 2000 potential cases.
Every doctor is being sent a warning about this newly identified trend in children utilizing Strattera therapy. Doctors who continue to prescribe the drug routinely despite these new warnings may also be at risk of legal action, should their young patients attempt or commit suicide.
