Treatment with antidepressants increases the risk of suicidal thoughts and behavior in patients up to age 24, according to proposed changes to the drugs' labels unveiled Wednesday by health officials. The proposal would expand a warning now on the labels that applies only to children and adolescents treated with the drugs.
How many people are affected by depression?
According to a report from the National Institute of Mental Health, nearly 18.8 million Americans over the age of 18 suffer from major depression. Suicide, closely linked to depression, is the third leading cause of death in 10- to 24-year-olds.
How many people take anti-depressants?
Overall use of antidepressants continues to grow, with nearly 190 million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company.
What are the FDA's concerns?
The FDA said the increased risk could mean as many as 14 additional cases of suicidal thoughts or behavior in every 1,000 children treated with antidepressants. For adults 18 to 24, there could be four additional such cases per 1,000.
What were the FDA's findings?
The FDA recently completed a mass review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated but short-term risk for suicidal thoughts and behavior among adults 18 to 24 that approaches that seen in children, the FDA said in documents released before Wednesday's meeting of its psychopharmacologic drugs advisory committee.
How do antidepressants work?
Although scientists don't know for sure, antidepressants appear to correct a chemical imbalance or dysfunction in the brains of depressed people. An antidepressant boosts the level of neurotransmitters important in fighting depression.
What are warnings to look for?
According to the FDA, health care providers and patients should be aware of the following:
Adults being treated with antidepressant medicines, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close observation of adults may be especially important when antidepressant medications are started for the first time or when doses for the specific drugs prescribed have been changed. Adults whose symptoms worsen while being treated with antidepressants, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.
Which drugs have a warning already?
Click here for a list of the drugs the FDA requires to have a label.
To learn more about anti-depressants:
• Click here to read more from the FDA.
• Read the FDA's public advisory here.
• The American Psychiatric Association has additional resources.
• You can read more about depression at WebMD.