FDA calls for black box on antidepressants

Share this article:
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.
Share this article:

Email Newsletters

More in News

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.