This information
reflects FDA’s current analysis of available data concerning these drugs.
Posting this information does not mean that FDA has concluded there is a causal
relationship between the drug product and the emerging safety issue. Nor
does it mean that FDA is advising health care professionals to discontinue
prescribing this product. FDA is considering, but has not reached a conclusion
about whether this information warrants any regulatory action. FDA
intends to update this document when additional information or analyses become
available.
FDA is investigating a
possible association between the use of Singulair and behavior/mood changes,
suicidality (suicidal thinking and behavior) and suicide. Singulair is a
medicine in the drug class known as leukotriene receptor antagonists.
Singulair is used to treat asthma and the symptoms of allergic rhinitis
(sneezing, stuffy nose, runny nose, itching of the nose) and to prevent
exercise-induced asthma.
Over the past year, the
maker of Singulair, Merck & Co, Inc., 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).
In February 2008, FDA
and Merck discussed how best to communicate these labeling changes to
prescribers and patients. Merck plans to highlight the recent changes in
the prescribing information in face-to-face interactions with prescribers and
provide prescribers with patient information leaflets about Singulair. The
Singulair website includes the most current prescribing information and patient
information for Singulair (
www.singulair.com).
FDA is working with
Merck to further evaluate a possible link between the use of Singulair and
behavior/mood changes, suicidality and suicide in response to inquiries
received by FDA. FDA has requested that Merck evaluate Singulair study data
for more information about suicidality and suicide. FDA is reviewing the
postmarketing reports it has received of behavior/mood changes, suicidality and
suicide in patients who took Singulair.
Due to the complexity
of the analyses, FDA anticipates that it may take up to 9 months to complete
the ongoing evaluations. As soon as this review is complete, FDA will
communicate the conclusions and recommendations to the public.
Singulair is an
effective medicine that is indicated for the treatment of asthma and symptoms
of allergic rhinitis. Patients should not stop taking Singulair before
talking to their doctor if they have questions about this new information.
Until further information is available, healthcare professionals and caregivers
should monitor patients taking Singulair for suicidality (suicidal thinking and
behavior) and changes in behavior and mood.
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. FDA is reviewing postmarketing reports
it has received of behavior/mood changes, suicidality and suicide in patients
who took Accolate, Zyflo, and Zyflo CR and will assess whether further
investigation is warranted.
This early
communication is in keeping with FDA’s commitment to inform the public about
its ongoing safety reviews of drugs.
The FDA urges both
healthcare professionals and patients to report side effects from the use of
Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event
Reporting program
http://www.fda.gov/Cder/drug/early_comm/montelukast.htm
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