FDA Checks Into Singulair Suicide Risk
Possible Link Between Singulair Use and Suicide Risk Isn't Certain; Investigation May Take 9 Months
March 27, 2008 -- The FDA today
announced that it is working with the drug company Merck to investigate a
possible link between Merck's asthma and allergy drug Singulair and behavior/mood changes, suicidality (suicidal thinking and
behavior), and suicide.
The FDA's investigation may take
nine months. As of now, there's no proof that Singulair directly affects
Meanwhile, the FDA calls Singulair
"effective" and advises patients with questions not to stop taking
Singulair before talking to their doctor.
The FDA also asks health care
professionals and caregivers to monitor patients taking Singulair for
suicidality and changes in behavior and mood.
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. It's in a class of drugs called leukotriene receptor
Other leukotriene modifying
medications include the asthma drugs Accolate, Zyflo,
and Zyflo CR. The 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
Singulair Time Line
The FDA notes that over the past year, Merck has updated Singulair's
prescribing information and patient information to include the following
postmarketing adverse events: tremor (March 2007), depression (April 2007),
suicidality (October 2007), and anxiousness (February 2008).
In February 2008, the FDA and Merck discussed how best to communicate these
labeling changes to prescribers and patients. According to the FDA, Merck
plans to highlight the recent changes in the prescribing information in
face-to-face interactions with prescribers and to provide prescribers patient
information leaflets about Singulair.
In response to inquiries received by the FDA, the FDA has asked Merck to
evaluate Singulair study data for more information about suicidality and
suicide. The FDA is also reviewing its postmarketing reports of behavior/mood
changes, suicidality, and suicide in patients who took Singulair.
Singulair's web site includes the most current prescribing information and
patient information for Singulair, according to the FDA.
Drug Companies Respond
"The notification by FDA is
not an indication that they believe that health care providers should change
their prescribing practices based on this alert," George Philip, MD,
Merck's senior director of clinical research and chair of the product
development team for Singulair worldwide, tells WebMD. "Instead, if
patients have questions, they should contact their doctor before making any
changes in their use of Singulair and should not stop Singluair on the basis of
Philip notes that postmarketing
reports "can be quite sketchy and difficult to make solid conclusions and
certainly not sufficient for us to conclude that Singulair has caused any
In 40 clinical studies of some
11,000 patients who took Singulair as part of a placebo-controlled trial, there
were no reports of suicide, according to Philip.