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Dr. Kim Mulvihill reporting A hot selling drug for ADHD just got slapped with a black box warning. The drug is sold under the brand name Strattera.
Eli Lilly introduced Strattera three years ago to treat ADHD in children, teens and adults. Today, the FDA announced this best seller must now carry the agency's strongest advisory-- a black box warning for children and teens.
Harold Koplewicz, M.D./ Child & Adolescent Psychiatry expert: "This is an important warning. It's good for parents to know about. It's good for parents and doctors to discuss."
This warning comes after new results from a clinical trial involving more than 13-hundred young people who were given Strattera. Five reported suicidal thoughts and one actually attempted suicide. No such suicidal thoughts took place among the kids taking a placebo.
While suicidal thoughts or an attempt is serious, you have to remember it happened with just a handful of patients. A low number that in the past would not have necessarily brought a black box warning.
Dr. Koplewicz: "We live in a very conservative and cautious period of time right now when it comes to psychiatric medications and children."
Not too long ago, the FDA also added black box warnings to several anti-depressants. Reports showed these drugs also led to suicidal thoughts in a small number of children.
Parents should watch for any changes in behavior or mood. If you or your child is presently taking Strattera, do not stop taking the drug without first consulting your physician or psychiatrist.