FDA Warns About ADHD Drug Strattera
The Food and Drug Administration warned doctors Thursday about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug used to treat attention deficit hyperactivity disorder.
Manufacturer Eli Lilly & Co. announced that a black-box warning will be added to the drug’s label in the United States. Such a warning is the most serious that can be added to a medication’s label, and similar warnings will be added to the drug’s labels in other countries. The company said a study showed instances of suicidal thinking were rare.
In a statement, the FDA said it “is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed.”
Eli Lilly said it provided the FDA results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, but survived, company and FDA officials said.
There was no evidence of increased suicidal thoughts in adults taking Strattera, which also goes by the generic name atomoxetine, the Indianapolis-based company said.
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One Comment to
“FDA Warns About ADHD Drug Strattera”
to whom it may concern,
my daughter has been on strattera since late august and i have had trouble with her mood swings, irratable ways, and also sying she wants to commit suicide. is this after effects of this drug? if so what drug can i have her put on in order to reduce these side effects? also she has developed an eating disorder because when she eats her stomach hurts and doesn’t want to eat and she feels sick after eating. as a concerned and worried parent i need your help in this matter.
thank you,
worried mother of adhd child
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