Several children's health experts are pushing the Food and Drug Administration to put "black box" suicide risk warning labels on Focalin, a drug commonly used to treat attention-deficit hyperactivity disorder in children as young as 6, Reuters reports. Here are details about ADHD drugs and associated safety concerns.
* An FDA advisory panel requested warnings be placed on Focalin in connection with reports of suicidal feelings from eight children. All said they took Focalin at some point during the last six years and experienced the suicidal thoughts, but the FDA linked only four cases to the medication.
* According to the Centers for Disease Control and Prevention's National Center on Birth Defects and Developmental Disabilities, ADHD is one of the most common parent-reported health concerns in children. 5.5 percent of children ages 4 to 10 have been diagnosed with ADHD. 8.6 percent of kids ages 11 to 14 have it and in 15- to 17-year-olds, more than 9 percent have been diagnosed with ADHD.
* Fewer children take medication for ADHD than are diagnosed with it. The highest age category for medicating is in children 11 to 14 years: More than 6 percent.
* Along with Focalin, Novartis markets Ritalin, which is also prescribed for children with ADHD. These medications are amphetamine stimulants; according to the National Institute of Mental Health, stimulants are used because they have a calming effect.
* Focusing problems, overactive behavior and impulsivity are benchmark characteristics of ADHD. Stimulants, which usually cause nervousness and erratic behavior in adults, have been shown to help children manage their behavior, improve concentration and even coordinate physical actions.
* 2.7 million people in the U.S. take medication for ADHD; 1.8 million children were prescribed Focalin from 2005 and 2011. The FDA is reluctant to enforce suicide warning labels on Focalin because no incidents of suicide thinking were reported in clinical trials and because the four reported suicide issues represent too small a population of children, Fox News reports.
* Strattera has been linked to increased thoughts of suicide in children and adolescents with ADHD. About 4 in 1,000 children experienced suicidal thoughts while taking Strattera.
* Parents are warned that children taking Focalin might experience psychotic or manic symptoms. The biggest concern is heart problems, the FDA says. Patients with heart conditions or family history of heart problems are warned it can cause heart attack and sudden death.
Marilisa Kinney Sachteleben writes about parenting issues from 23 years raising four children and 23 years teaching K-8, special needs, adult education and home-school.
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