ROCKVILLE, Md., March 27 -- The FDA said it will probably take at least nine months for it to complete a safety review of the popular asthma and allergy drug montelukast (Singulair).
The ongoing investigation is examining a possible association between use of the drug and behavior/mood changes, suicidality (suicidal thoughts and behavior), and suicide, the agency said.
Today's release of a statement about the ongoing safety review does not mean that the agency has concluded that there is a causal relationship between montelukast and "an emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product," the FDA said.
But the agency is considering the possibility that the safety issues might require regulatory action.
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 (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).
Montelukast 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."