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

Antidepressant black boxes updated

Executive Summary

Class labeling for antidepressants is updated Aug. 2 to include warnings about increased risks of suicidality in young adults ages 18 to 24. The new language, which FDA proposed in May, states that risk was not seen in adults older than 24 and that the risk decreased for adults ages 65 and older (1"The Pink Sheet" May 7, 2007, p. 32). Also added is a statement that "Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide." The Psychopharmacologic Drugs Advisory Committee voted to recommend the changes at a 2006 meeting on the risk of drug-related suicidality in adults (2"The Pink Sheet" Dec. 18, 2006, p. 3). The black box warning on suicidality in pediatric patients was first added in 2005...

Latest Headlines
See All
UsernamePublicRestriction

Register

PS048662

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