Byline: Gregory Lopes, THE WASHINGTON TIMES
Young adults beginning treatment for depression should be warned about increased risks of suicidal tendencies, federal health officials said yesterday.
The Food and Drug Administration has new data showing 18- to 24-year-olds taking antidepressant drugs are experiencing a "slight increase" in suicidal thinking and behavior. As a result, the agency yesterday sent letters to all manufacturers of antidepressant medications asking them to update current suicide warnings for children and teens to include such warnings for young adults.
"We fully expect all the companies to adopt this language," said Thomas Laughren, director of the FDA's psychiatric products division. "Ultimately, they don't have any choice, and they should want to."
Every drug company that makes an antidepressant is being asked to include new warnings to young adults within 30 days. Popular antidepressants that will be affected include Lexapro, made by Forest Laboratories Inc.; Paxil, made by GlaxoSmithKline PLC; Prozac, made by Eli Lilly and Co.; and Zoloft, made by Pfizer Inc.
About 16 million Americans take antidepressants, according to the American Psychiatric Association.
The first set of warning labels on antidepressant drugs appeared in 2004, in the form of a "black box" warning. Such a warning, named for the black border that usually surrounds the text, means that medical studies indicate the drug carries a significant risk of serious or life-threatening side effects.
The initial warnings were aimed at children and adolescents. But the FDA then began a comprehensive review of 295 antidepressant trials that included more than 77,000 adult patients with severe psychiatric disorders.
Dr. Laughren said the new data show that out of 1,000 patients taking both an antidepressant and a placebo drug, five patients taking the actual drug showed signs of suicidal behavior. …