FDA Checks Into Singulair Suicide Risk
Possible Link Between Singulair Use and Suicide Risk Isn't Certain; Investigation May Take 9 Months
WebMD News Archive
Drug Companies Respond continued...
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.
And in other studies comparing
Singulair to other types of asthma therapies including inhaled corticosteroids and
long-acting beta agonists, out of roughly 3,900 patients taking Singulair and
3,400 using other asthma treatments, one patient
taking Singulair and three patients taking other asthma treatments attempted --
but did not complete -- suicide.
Accolate is made by AstraZeneca.
"AstraZeneca is aware of the posting by the FDA, but to date has not been
asked for any further information," Blair Hains, AstraZencea spokesman,
Zyflo and Zyflo CR are made by
Critical Therapeutics. "We are actively reviewing our current safety
database and will take appropriate action if deemed necessary," Linda
Lennox, Critical Therapeutics' vice president for investor and media relations,
tells WebMD via email.
Asthma, Allergy Doctors Respond
The American College of Allergy, Asthma & Immunology and the
American Academy of Allergy, Asthma & Immunology issued a joint
statement about the FDA's announcement.
"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," the statement reads.
The statement also recommends that "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."
Report Adverse Events
The FDA urges health care 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.
MedWatch reports can be filed the following ways:
- On the FDA's web
- By returning the postage-paid FDA form 3500 to 5600 Fishers
Lane, Rockville, MD 20852-9787
- By faxing the form to 800-FDA-0178
- By phone at 800-332-1088