October 22, 2004
The U.S. Food and Drug Administration (FDA) has directed drug companies to put the government's most serious warning label - a prominent "black box" - on all antidepressant medications, stating the possibility of a rare increased risk of suicidal thoughts and actions in children and teens taking the medications. The FDA will has also instructed drug companies to include an easy-to-understand Patient Medication Guide (MedGuide) with all prescriptions of antidepressant drugs.
The decision comes after FDA advisers strongly recommended the label in a 2-day hearing last month, when experts maintained that 2 or 3 out of every 100 children on antidepressants might be at an increased risk of exhibiting suicidal thoughts and behaviors.
What Is Depression?
Depression can impact children, just as it can adults, though the signs and symptoms in kids can appear significantly different - and include school failure, lack of concentration, agitation, risk-taking, and mood changes, as well as sleep and eating disturbances. Depression that isn't diagnosed or adequately treated increases the risk of self-harming behaviors such as cutting and suicide. Proper diagnosis of depression and treatment is important to help children function at their best.
There are a variety of effective treatments for depression. Sometimes these include medication. Some studies have shown that one group of drugs, called selective serotonin reuptake inhibitors, or SSRIs, may help children who have certain mental health conditions such as depression and obsessive-compulsive disorder.
Like any treatment, the benefits of antidepressant medication need to be weighed against possible risks. In the case of some antidepressants, some studies have suggested that some children on antidepressant medications may have increased suicidal thoughts - though, in the studies, no actual suicides occurred.
What You Should Do
To be cautious, parents should watch for increased signs of depression and suicidal thoughts or actions in children who take antidepressants, especially during the days and weeks when a child first starts taking a medication or when the dosage (the amount of medication prescribed) is changed.
Individual children react differently to medications, but some of the things you should watch out for if your child is taking antidepressants include:
- suicidal thoughts
- signs that your child's depression may be continuing or worsening, such as persistent sadness, low energy, changes in appetite and sleeping patterns, and an inability to enjoy life
- signs of anxiety, such as increased stress and worry over everyday situations, nervousness or nervous movements, a racing heartbeat, and possible physical symptoms like unexplained stomachaches or headaches
- increased agitation
- severe restlessness
- panic attacks - episodes of intense fear that occur for no apparent reason
- insomnia, such as trouble falling asleep or staying asleep
- signs of irritability, such as a quick temper or hostility toward others
- impulsive behavior
- mania - an abnormally elevated or euphoric ("high") mood that typically includes racing thoughts, increased activity and talkativeness, and less need for sleep. An increase in risk-taking behaviors may also occur.
If you notice any of these changes in your child who is taking antidepressants, report them to your child's doctor immediately.
The FDA is not recommending that children stop taking antidepressants. In fact, suddenly discontinuing or changing the dose of a medication can cause more problems. Don't stop giving your child antidepressant medications without the guidance of your child's psychiatrist or doctor. Instead, talk to him or her about your concerns.
Reviewed by: Neil Izenberg, MD
Date reviewed: October 2004
