Asthma Drug Linked to Depression, Anxiety and Suicide
Singulair, the popular asthma and allergy drug, may cause tremors, depression, suicidality (suicidal thinking and behavior) and anxiousness.
The popular asthma and allergy drug montelukast (Singulair) is linked to suicidality (suicidal thoughts and behavior) and suicide, FDA said.
However, the results of the study do not mean that "FDA is advising healthcare professionals to discontinue prescribing this product," the FDA said.
Over the past year, the maker of Singulair, Merck & Co, has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor, depression, suicidality (suicidal thinking and behavior) and anxiousness.
Singulair is a leukotriene receptor antagonist indicated for asthma, allergic rhinitis, and to prevent exercise-induced asthma.
Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor.
The FDA said it was also reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took those drugs and "will assess whether further investigation is warranted."
The FDA said it will probably take at least nine months for it to complete a safety review of Singulair.