The FDA said the labels, which already include similar warnings for children and adolescents, should also warn young-adult consumers about a risk of developing suicidal thoughts during initial treatment, generally in the first one to two months.
Federal health authorities said that the new changes would also include text stating that scientific data does not show such an increased suicidal risk in adults older than 24, and that adults aged 65 and older who take anti-depressants are at lower risk of experiencing suicidal ideation.
The new warnings would also indicate that depression and certain other serious psychiatric disorders are the main causes of suicide. The FDA has now given the manufacturers of anti-depressants a deadline of 30 days to submit their revised product labels and revised medication guidelines for review.
Eli Lilly as said in a statement, "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."
Other companies that have agreed to the new proposal include Zoloft manufacturer Pfizer Inc.
