The FDA has proposed that manufacturers update product labeling to include warnings that antidepressants may increase the risk of suicide in adults ages 18 to 24.
The FDA has proposed that makers of antidepressant drugs update the labels on their products to include a warning to adults ages 18 to 24 that the drugs may increase their risk of suicide. Currently, the labels warn only that children and adolescents who use the drugs have an increased risk of suicidal thoughts and behavior, known as suicidality.
In clinical trials, young adults who were prescribed antidepressants had a slightly higher risk of suicidality than those who received a placebo. While no participant died of suicide, the administration says the evidence is strong enough to warrant label changes.
The proposed changes will include language stating that evidence does not show an increased risk in adults older than 24; that adults ages 65 and older taking antidepressants have a decreased risk of suicidality; and that depression and psychiatric disorders are themselves the most important causes of suicide.
Manufacturers of antidepressants will have 30 days to submit their revised labels and medication guides for review. Those currently taking prescribed antidepressants should not discontinue use, but rather consult their health care providers if they have questions or concerns.