FDA Checks Into Singulair Suicide Risk
Possible Link Between Singulair Use and Suicide Risk Isn't Certain; Investigation May Take 9 Months
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 particular effect."
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, tells WebMD.
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 site
- 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