FDA: Advise young on drugs
By ASSOCIATED PRESS
Published May 3, 2007
WASHINGTON - Young adults face an increased risk of suicidal thoughts and behavior when they first begin taking antidepressants and should be warned about the danger, federal health officials said Wednesday.
The Food and Drug Administration asked makers of the drugs to expand warning labels to include adults age 18-24. The labels already include similar warnings for children and adolescents.
Eli Lilly and Co., the maker of Prozac; Zoloft manufacturer Pfizer Inc.; and other pharmaceutical companies said they would comply with the FDA's request.
"We believe this step will help ensure that the millions of people with depression who are young adults age 24 and under and their families can make informed treatment decisions while minimizing the fear and stigma associated with depression, " Eli Lilly said in a statement.
Pfizer spokeswoman Shreya Prudlo said the company would update its label, which she said already calls for close monitoring of patients when they begin taking Zoloft. She added, however, "There is no established causal link between Zoloft and suicide in adults, young adults or children."
The proposed labeling changes would note that studies have not shown this increased risk in adults older than 24 and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior.
The expanded warnings would emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks, " said Dr. Steven Galson, the FDA's drugs chief.
The FDA advises that patients of all ages starting on antidepressants should be "monitored appropriately and observed closely" for worsening symptoms, suicidal thoughts or behaviors or unusual changes in behavior.
Still, any risks are small. For every 1, 000 patients 18-24 treated with antidepressants, the FDA would expect there would be five additional patients who have suicidal thoughts or exhibit suicidal behavior, said Dr. Thomas Laughren, who oversees psychiatric drugs for the FDA. The FDA analysis was based on studies of 11 antidepressants in more than 77, 000 patients.
The risk: Young adults face an increased risk of suicidal thoughts and behavior when they first begin taking antidepressants, and drugmakers should warn people age 18-24 about the dangers, the Food and Drug Administration said.
Already included: Drug labels already include warnings for children and adolescents.
Industry cooperating: Drug companies said they would comply with the FDA's request.