FDA calls for black box on antidepressants
The FDA will require that all antidepressants carry a "black box" warning highlighting the increased risk of suicidal thoughts and behavior in children and adolescents.
The "black box" warning is the most serious warning that can be placed in the labeling of prescription medication and calls for limits to be placed on advertising of the labeled products. Advertisements for drugs with the label designation, known throughout the industry as reminder ads, are forbidden. Also, the information within the boxed warning must appear in any printed ad material and must be stated exactly within any non-printed material.
In 2003, the SSRI/SNRI antidepressants category ranked third among therapeutic classes with sales of $10.9 billion in the United States, according to IMS Health. Pfizer's Zoloft, was the top-seller at roughly $2.6 billion.
Eli Lilly's Prozac is the only medication approved to treat depression in children and adults.