FDA: No Suicide Risk From Singulair
FDA's Review Shows No Link Between Suicide and Asthma Drugs Singulair, Accolate, Zyflo, or Zyflo CR
Jan. 13, 2009 -- The FDA today announced that it sees no sign of an
association between the asthma drugs Singulair, Accolate, Zyflo, or Zyflo CR
and suicide risk.
The FDA began reviewing safety data on those four drugs and suicide,
suicidality (suicidal thinking and behavior) and other behavior and mood
The agency now concludes that the data "do not suggest" that
Singulair, Accolate, Zyflo, or Zyflo CR are associated with suicide or suicidal
behavior, although the data came from clinical trials that weren't designed to
examine such events.
The FDA reached those conclusions based on data from 41 clinical trials of
Singulair, 45 clinical trials of Accolate, and 11 trials of zileuton (the
active ingredient in Zyflo and Zylfo CR). Each of those drugs was compared to a
placebo, but the studies weren't head-to-head comparisons of the asthma
The data show no suicides among patients taking any of the asthma drugs and
only one case of suicidal thinking in an asthma drug user, which occurred in
one out of 9,929 patients treated with Singulair. For comparison, there was one
suicide and one case of suicidal thinking in the placebo group in the Accolate
trials, and no reports of suicides or suicidal thinking in the zileuton
Singulair is made by the drug company Merck. Accolate is made by the drug
company AstraZeneca. Zyflo and Zyflo CR are made by the drug company
"We're pleased with the conclusions," Alan Ezekowitz, MBChB, DPhil,
Merck's senior vice president and franchise head for respiratory diseases,
Ezekowitz notes that ever since the FDA's review began, the American College
of Allergy, Asthma & Immunology and the American Academy of Allergy, Asthma
& Immunology have recommended that patients should keep taking their
asthma drugs as prescribed and consult their physicians with any questions.
The FDA is still reviewing clinical trial data on other behavioral and mood
events related to those asthma drugs, which all affect the leukotriene pathway,
which is involved in the body's response to inflammatory stimuli (such as
breathing in an allergen).