FDA Issues Warning About ADHD Drug Strattera

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ADHD Drug Alert

FDA has issued a public health alert about the increased risk of suicidal thinking in children and teens being treated with Strattera. Strattera is currently approved in the United States to treat attention deficit hyperactivity disorder (ADHD) in children, teens, and adults.

The alert was based on studies of 2,200 children. One child who was taking Strattera tried to kill himself. Other studies showed that four in 1,000 children treated with Strattera thought about killing themselves. This means that 996 out of 1,000 children did not think about suicide.

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Health care professionals and caregivers are advised to watch for any behavior changes in children and teens taking Strattera. Parents and patients should discuss any changes in behavior with the child's doctor. These include increased agitation, irritability, or suicidal thinking. This is especially important at the beginning of treatment or when doses are changed.

In addition, the FDA has asked the maker of Strattera, Eli Lilly and Co., to add a boxed warning to its label and to develop a medication guide that includes this new risk information. Pharmacists will give the medication guide to patients, families, and caregivers with each prescription or refill of Strattera.

The FDA does not advise people to stop taking Strattera but only to watch for signs of suicidal thinking. More information is available from the FDA at (888) 463-6332 or on the web at www.fda.gov

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