ADHD Drugs include Adderall, Concerta, Cylert, Metadate, Methylin, Ritalin and Strattera
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ZyprexaADHD DRUGS: STRATTERA
A Public Health Advisory has been issued by the FDA to alert physicians to reports of suicidal thinking in children and adolescents associated with Strattera (atomoxetine). Strattera is approved to treat attention-deficit hyperactivity disorder (ADHD).
The FDA is advising health care providers, parents, and other caregivers to closely monitor children and adolescents being treated with Strattera. Patients should be monitored for worsening symptoms including agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior. Special attention should be paid to symptoms during the first few months of therapy or when the drug dose is increased or decreased. Caregivers and those taking Strattera who have concerns or questions about these symptoms should contact their health care provider.
The FDA also has directed the manufacturer of Strattera, Eli Lilly and Co. of Indianapolis, to develop a Medication Guide for patients and caregivers. The Medication Guide is intended to be distributed by the pharmacist with each prescription or refill of the drug.
Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, describes the FDA's action as "another example of the agency acting swiftly to alert the public to significant drug safety information needed to use a drug in a safe manner."
An analysis of the manufacturer's clinical trials database, which included 1,350 people receiving Strattera and 851 receiving a placebo, showed that 0.4 percent of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo. There was one suicide attempt by a patient who received Strattera among the approximately 2,200 children in the trials.
Strattera has been on the market since 2002 and has been used in more than 2 million patients. It is currently approved in the United States to treat ADHD in children, adolescents, and adults. Strattera has not been studied in children younger than 6 years.
