Asthma medication evaluated for possible link to behavioural/mood and suicidality
By Susan Jeffrey
By Susan Jeffrey
Information from Industry
March 27, 2008 — The US Food and Drug Administration (FDA) has issued a MedWatch safety alert informing doctors and patients that it is investigating a possible link between use of montelukast (Singulair, Merck) and changes in mood and behavior as well as suicidality and suicide.
The drug, a leukotriene-receptor antagonist, is indicated for the treatment of asthma and symptoms of allergic rhinitis and to prevent exercise-induced asthma.
The agency is working with Merck to evaluate the possible link in response to inquiries it has received, the alert notes, and has asked Merck to review its study data for more information about suicidality and suicide.
"Due to the complexity of the analyses, the FDA anticipates that it may take up to 9 months to complete the ongoing evaluations," the alert notes. "As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public."
The statement emphasizes, though, that "posting this information does not mean that the FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that the FDA is advising healthcare professionals to discontinue prescribing this product. The FDA is considering but has not reached a conclusion about whether this information warrants any regulatory action."
Over the past year, Merck has updated the prescribing and patient information on montelukast to include a number of adverse events found in postmarketing surveillance, including tremor, depression, suicidality, and anxiousness, the alert notes. In February 2008, the FDA and Merck discussed how best to communicate these changes, including face-to-face interactions with prescribers and provision of patient-information leaflets.
Patients should not stop taking montelukast before talking to their doctor about the new information, the alert adds. Healthcare professionals and caregivers are encouraged to monitor patients for any of these changes.
The FDA is also reviewing postmarketing reports of behavior/mood changes, suicidality, and suicide in other leukotriene-modifying medications, including zafirlukast (Accolate, AstraZeneca), also a leukotriene-receptor antagonist, and zileuton (Zyflo and Zyflo CR, Critical Therapeutics), a leukotriene-synthesis inhibitor, and plans to assess whether further investigation is warranted.
The agency urges healthcare professionals and patients to report adverse effects from use of any of these agents to the MedWatch Adverse Event Reporting System.