Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

US FDA Orders Singulair Boxed Warning On Neuropsychiatric Events Despite ‘Limited’ Evidence

Executive Summary

Therapeutic alternatives and lack of prescriber and parent knowledge about existing warnings drove agency’s decision, despite internal concerns about the adequacy of the evidence to support the safety action.

You may also be interested in...



'Dear Doctor Mom' – US FDA Urged To Find Way To Reach Pediatric Patient Parents With Safety Updates

How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.

Safety Communications: US FDA Panel Offers Menu Of Options For Singulair's Risks

A common theme among the public speakers at the advisory committee was that their children's prescribers never informed them of the existing warning and precaution in the label. With that in mind, the US FDA now heads to the drawing board after a joint panel offers a series of options to more effectively communicate the potential neuropsychiatric risks associated with Singulair.

Black Box On Singulair Doubtful After US FDA Panel Offers Divided Opinion

Joint panel of the Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee was split on whether the US FDA should add a black box warning to the label of Merck's now generic Singulair, which is currently labeled with a warning and precaution about a risk of psychiatric events.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141795

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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