Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA May Revisit Antidepressant “Black Box” Suicidality Warning

Executive Summary

FDA will monitor emerging data on suicides and antidepressants as it becomes available to determine if an uptick in suicides among adolescents is associated with the decline in prescriptions for antidepressants that followed the addition of a "black box" warning to labeling for the products

You may also be interested in...



Class Labeling For Anti-epileptics Embraces Lessons From Antidepressants

Anti-epileptic drug sponsors have until mid-January to decide whether to fight FDA-mandated labeling changes and a REMS program after a meta-analysis showed a statistically significant increase in suicidality.

Class Labeling For Anti-epileptics Embraces Lessons From Antidepressants

Anti-epileptic drug sponsors have until mid-January to decide whether to fight FDA-mandated labeling changes and a REMS program after a meta-analysis showed a statistically significant increase in suicidality.

Antiepileptics Show Risk Of Suicidality, May Cause Labeling Convulsions

FDA findings of an increased risk of suicidality in patients given antiepileptic drugs will likely lead to broad class labeling changes, according to a MedWatch alert issued Jan. 31

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS048325

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel