Mon, Jul 06, 2009

Washington

Antidepressant warning expands to young adults

The Associated Press
Tucson, Arizona | Published: 05.03.2007
WASHINGTON — Young adults face an increased risk of suicidal thoughts and behavior when they first begin taking anti- depressants and should be warned of the danger, federal health officials said Wednesday.
The Food and Drug Administration asked makers of the drugs to expand their warning labels to include adults ages 18 through 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," 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, that "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 chief of pharmaceuticals.