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Montelukast Gets Boxed Warning for MH Effects
The Food and Drug Administration is now requiring a boxed warning for montelukast, which is sold under the brand name Singular and in generic form to treat asthma and hay fever (allergic rhinitis). The boxed warning strengthens an existing warning about the risks of neuropsychiatric events with montelukast such as agitation, depression, sleep problems, and suicidal thoughts and actions. The warning advises health professionals to avoid prescribing montelukast for patients with mild symptoms, particularly those with hay fever.
The FDA required the boxed warning after reviewing multiple reports of suicide and other adverse events by patients taking the medication. This included reports submitted through the agency’s Adverse Event Reporting System (FAERS) and studies published in the medical literature. The FDA had also conducted a study using data in the Sentinel Distributed Database, which is generated from patient interactions in the U.S. health care system through their insurers and health care professionals.
“For allergic rhinitis in particular, the FDA has determined that montelukast should be reserved for patients who have not responded adequately to other therapies or who cannot tolerate these therapies,” the agency said in a March 4 Drug Safety Communication.
Deutetrabenazine Fails Trials for Children With Tourette’s Syndrome
In February Teva Pharmaceutical Industries Ltd. announced that Austedo (deutetrabenazine) did not meet the primary endpoints of trials comparing the drug with placebo for the treatment of tics in pediatric patients with moderate to severe Tourette’s syndrome. Austedo is approved for chorea associated with Huntington’s disease and for tardive dyskinesia in adults.
The ARTISTS 1 and ARTISTSS2 studies evaluated the safety, tolerability, and efficacy of Austedo compared with placebo in youth aged 6 to 16 years with moderate to severe Tourette’s syndrome. ARTISTS1 was a 12-week comparison study whereas ARTISTS2 was an eight-week study that included two different doses of deutetrabenazine. The primary endpoint for both studies was the change in the Yale Global Tic Severity Scale from baseline to end of study.
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