Kids and Antidepressants: A Growing Problem (cont.)
In October 2004, the FDA, following recommendations of the advisory committee, ordered makers of all antidepressant medications - not just SSRIs -- to include a "black box" warning and cautionary statements on drug labeling that will "alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents."
Britain's Medicines and Healthcare Products Regulatory Agency issued similar warnings in early December, urging doctors to consider alternative therapies and, when prescribing an antidepressant, to prescribe only low doses and monitor patients carefully.
In the pharmaceutical industry, a black box on a product's label is a stark reminder that for every benefit, every "miracle drug," there is a risk. In the case of widely prescribed and heavily marketed antidepressants, the benefits of relief from symptoms of major clinical depression must be weighed against the relatively infrequent but potentially devastating risks of worsening of depression or suicide.
There is little dispute that antidepressants have helped millions of adults with major depression and other debilitating mental disorders. There is also, however, growing concern among doctors, child safety advocates, and parents that these heavily marketed mind-altering agents are being used too freely and with too little research into their effects in children and adolescents.
In a statement praising the FDA's action in March, Martha Hellander, JD, executive director of the Child and Adolescent Bipolar Foundation, called it "a wake-up call that these powerful and lifesaving drugs used to heal depression may trigger a paradoxical response in some children that parents need to know about."
Watch Out for Bipolar
The risks are higher in depressed children with a family history of bipolar disorder (formerly called manic depression) or who have existing symptoms of mania.
A doctor who served on the FDA Pediatric Advisory Committee tells WebMD that the risk of increased suicidality with antidepressants is incontrovertible. The unanswered question, says Thomas Newman MD, MPH, is whether the drugs work well enough in adolescents to justify taking the risk.
"There's no question that in the short term the drugs increase suicidality, but that doesn't really answer the question about benefits vs. risk. I think that we do need more data to know how effective they are ... whether there is some way of predicting in whom they will have favorable vs. adverse effects, and the whole area of what happens after you've been taking them for a long time or how you should stop them. Anything beyond the short-term trials that have been done we need more data on."