The FDA has instructed Eli Lilly to place a prominent “black box” warning on its popular drug Strattera used to treat attention problems in children. The black box warning is the FDA’s most serious alert. The drug maker had previously conducted a search of its data from clinical trials and analyzed reports of suicidal thinking among patients taking the drug. In the review from 12 trials involving 1,357 children and adolescents who took Strattera, 5 or 0.4 percent had suicidal thoughts serious enough to report to their doctor. One child attempted suicide. None of those on placebo reported suicidal thinking.
The black box warning for Strattera is similar to the same warning label required for antidepressant medications used for children that the FDA ordered in October of 2004. The FDA had previously announced that about 4 percent of minors taking most antidepressants reported suicidal thoughts. In response to these reports and concerns the National Health Service in Great Britain has instructed doctors to stop using antidepressants in children with mild depression. In December 2004 the Medicines and Healthcare Regulatory Authority told doctors that most antidepressants were unsuitable for children, but they left it up to doctors to decide whether or not to continue using them. The guidelines released by the National Institute for Health and Clinical Excellence in September 2005 go a step further, instructing physicians to offer psychological therapy lasting for at least three months instead of using antidepressants for less severe forms of depression. They also stated that drugs should only be offered in tandem with, and not instead of, therapy.
The Holistic Pediatric Association urges physicians and other pediatric health care providers to treat depression, attention problems, and other behavior disorders in children with holistic methods prior to considering drugs. These holistic methods may include the use of nutritional supplements, safe herbal formulas, acupuncture, and homeopathy as well as counseling and psychotherapy.