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FDA Says Some Antidepressants Must Carry Stronger Suicide Warnings
March 22, 2004 -- The FDA has ruled that 10 antidepressant drugs must carry on their labels.
The government agency said, Monday, the "warnings" section of the package insert should encourage close observation for worsening depression or the emergence of suicidal thinking and behavior in both adult and pediatric patients being treated with these agents, particularly for depression but also for other psychiatric and nonpsychiatric disorders.
What does this mean to patients? For answers, WebMD turned to two experts:
Should my child or I stop taking my antidepressants?
Dr. Levy: "Absolutely not. Child and adolescent depression affects 3% to 5% of children. It is a serious illness, but it is treatable. Antidepressants aren't the only treatment. But any person with depression -- adult or child -- should talk to psychiatrist about it. It's important to remember that 15% of untreated depression ends in suicide. To abruptly respond with panic is much more dangerous than the risk of staying on the drugs."
Dr. Hanna: "This question would have to be addressed to the clinician prescribing the medication. Most child and adolescent psychiatrists feel comfortable with prescribing the new antidepressants. Some of these medications have been in use for well over 10 years. Clinicians have the sense that these drugs are effective and can be used safely. Before Prozac became available in 1990, we often used antidepressants never shown to be effective in children and that were more toxic. So we still think of these newer antidepressants as being a significant advance."
Are there other options for treating depression?
Dr. Levy: "I have a bias here, because I am a psychiatrist. If at all possible, I believe that a person with depression should be treated by a psychiatrist rather than by a psychologist or general practitioner, because depression is an illness. For many people, antidepressant treatment is an enormously important component of psychotherapy. Understanding the individual patient, and his or her medical background, is essential. I've found that a patchwork quilt of antidepressants plus talk therapy is much more effective then either one alone."
Dr. Hanna: "Yes, there are several psychotherapies in use. Especially for children and adolescents, we often try to use one or more psychotherapeutic methods first before using antidepressant medications. But if the depression is moderate to severe -- especially if it verges on hospitalization -- we will merge medication with psychotherapy. If you're going to try antidepressants, it is necessary to see a physician. It is more of a problem if the physician has less experience with treating children with depression. Most child and adolescent psychiatrists are well equipped to carry out such trials."
What are the warning signs I should look for (symptoms and signs)?
Levy: "The warning signs are the same as the warning signs in depressed people not taking antidepressants. Look for a disruption in work and play. You may find depressed children who become withdrawn, who become isolated, who no longer do activities they enjoy. Look for disruption in sleep or other physiological parameters -- such as enormous weight gain or loss.
"The other thing is talk to your child. Don't be afraid to ask your child, 'Are you sad? Are you feeling that life isn't worth it?' Talk to them. That is the best first aid. And it is the best way to intercept a child who is thinking of acting on suicidality.
The other dimension is impulsive behavior, particularly by adolescents. That is difficult to tease out from normal behavior. But obviously, if the impulse is to act in some life-threatening way, I would call the prescribing doctor right away and have the kid evaluated on an urgent if not emergency basis. And see a psychiatrist: He or she will be much more tuned-in to the specific risks of depression and antidepressant drugs."
Dr. Hanna: "Sometimes these signs and symptoms can be part of the medication, but sometimes they can be part of the depression. Look for an increase in anxiety, an increase in agitation -- a physical restlessness that is very uncomfortable. Other symptoms include panic attacks, insomnia, irritability, impulsivity, recklessness, and hypomania -- that's an expansive or grandiose mood that can lead to impulse behaviors. Another possible symptom is mania, which is the more extreme form one that's continuum, where a person can become psychotic or have delusions of extraordinary powers.
"One important point is the side effects, if they occur, they tend to develop in the first two days or week of treatment. It is important to keep in mind [patients] may develop side effects before they get relief -- but as they continue on the drug, the risk of side effects becomes less. If a person is doing well for four to eight weeks on an antidepressant, it is very unusual for something adverse to happen.
If parents see these symptoms, they should contact the treating physician. If they can't get hold of the doctor quickly, it is best not to stop the medication. Some of these drugs can produce side effects if stopped abruptly."
The FDA says everyone taking one of these drugs -- for whatever reason -- is included in the warning. Have you seen any sign of increased suicide risk in patients taking antidepressants for conditions other than depression?
Dr. Hanna: "I am unaware of any new concerns about increased suicidality in those being treated for something other than depression. We do treat a significant number of kids with obsessive-compulsive disorder with these drugs. I see a lot of these, and I have not seen any increase in suicidality or reckless behavior."
SOURCES: Mark Levy, MD, assistant clinical professor of psychiatry, University of California, San Francisco. Gregory Hanna, MD, director, section of child and adolescent psychiatry, University of Michigan, Ann Arbor.
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