Black Box On Singulair Doubtful After US FDA Panel Offers Divided Opinion
Executive Summary
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.
You may also be interested in...
Singulair’s Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining
Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.
US FDA Orders Singulair Boxed Warning On Neuropsychiatric Events Despite ‘Limited’ Evidence
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.
'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.