Joint Statement On FDA Investigation Of Singulair From The AAAAI And ACAAI

Main Category: Respiratory / Asthma
Also Included In: Allergy
Article Date: 31 Mar 2008 - 4:00 PDT

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Leadership from the American Academy of Allergy Asthma & Immunology and the American College of Allergy, Asthma & Immunology released the following statement in response to the Thursday announcement of a Food and Drug Administration investigation into Singulair:

There are no data from well-designed studies to indicate a link between Singulair and suicide. The concern expressed by the FDA is based entirely on case reports and there is no indication that such effects apply to other leukotriene-modifying medications.

Post-marketing case reports are incomplete. Furthermore, comparative data are lacking on the incidence of suicide in the general population versus the incidence in patients taking Singulair. Thus, it is unknown whether there is an increased incidence of suicide in patients receiving Singulair.

Based on the information currently available, patients taking Singulair should continue to take the medication as prescribed provided: 1) the patient and physician feel the medication is effective; and 2) the patient does not experience any suicidal behavior or thoughts.

Patients who experience suicidal thoughts or demonstrate suicidal behavior should consult their physician immediately to discuss whether to continue with this medication. Patients should not hesitate to consult their physician if they feel uncomfortable continuing on the medication.

American Academy of Allergy Asthma & Immunology