"The so-called black box warning extends a similar labeling change approved in 2004 for children and adolescents. "

"The action comes nearly five months after an FDA advisory committee recommended the warnings after finding a small increase in suicidal thoughts and behavior among young adults taking 11 commonly used antidepressants. The agency said 5 of every 1,000 patients age 18 to 24 were at increased risk. The FDA analysis was based on studies of 11 antidepressants in more than 77,000 patients. "

""The risk is small but the risk is real, and it is something that needs to be paid attention to," Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said during a news conference. "

"The FDA's action requires drug companies to submit proposed labeling and updated medication guides within 30 days. A total of 36 drugs would display the new warning. "

"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." "

"About 19 million people in the United States have depression and 16 million are treated with antidepressants. People under 25 account for about 8 percent of antidepressant prescriptions. "

"In an unusual move, Laughren said the new labels would carry both
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