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Printable Side Effect Alert

FOX 5 Investigates Singulair

Adverse effects of montelukast examined by FDA's Pediatric Advisory Committee

Psychiatric adverse drug events prominent in certain drugs prescribed for kids

Popular Asthma Drug's Deadly Side-Effects Revealed

After son's suicide, campaign by Queensbury pair leads to warning label on Singulair Jennifer A. Dlouhy, Washington Bureau Timesunion.com, October 21, 2009

Canadian Adverse Reaction Newsletter Vol. 19 - Issue 3 - July 2009 Provides details of the neuropsychiatric adverse events reported in connection with Singulair. 

Asthma drug linked to suicide attempts, thoughts of self-harm Bradley Bouzane, Canwest News Service, July 7, 2009. Mental health experts in Canada voice concern over Singulair's side effects.

Merck talks about taking Singulair Over the Counter (without a prescription)

Chantix and Zyban receive "Black Box" Warnings and medication guides from FDA for similar post-marketing adverse reactions as SINGULAIR.

Mentor mom Lynne Faraone helped sound the alarm over side effects from popular Singulair Diane Suchetka, Plain Dealer Reporter, Cleveland, OH, June 29, 2009. Lynne Faraone and seven other mothers fought for warning labels about the potential side effects of Singulair after they saw their impact on family members.

Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) 6/12/2009, Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).  FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).

FDA Flags Psychiatric Risks Of Asthma Drugs; New Labels Must Highlight Warnings, Matthew Perrone, AP Business Writer, June 12, 2009

UPDATE: FDA Updates Singulair Label For Neuropsychiatric Events, Jennifer Corbett Dooren  of DOW JONES NEWSWIRES, Wall Styreet Journal, June 12, 2009 

FDA Wants New Warning for Merck's Singulair CNBC News aired June 12, 2009

FDA Waved Through Asthma Drugs Despite Falsified Trials Newsblaze.com, 
Martha Rosenberg, May 22, 2009. A major allergy and respiratory management company is accused of knowingly producing flawed clinical trials, corrupted by protocol violations and outright falsifications, of FDA approved drugs including SINGULAIR.

Institute for Safe Medication Practices: QuarterWatch: 2008 Q3 May 2009.
The ISMP reported a system-wide error in the FDA's Adverse Event Reporting System. Additionally, they reported that some drug manufacturers used different names to identify the same drugs in reports submitted in the same quarter.

Drug fact sheets may omit facts consumers need, Cara Restelli, KY3 News, April 30, 2009. Very informative report about Singulair and pharmacy Consumer Medication Information.

Singulair Study Sifts Data Cathleen F. Crowley, Times Union, January 27, 2009
This is an excellent article, with quotes from Thomas J. Moore of the ISMP.

Mental Health Association in Pennsylvania: Behavioral Side Effect Warning Issued on Singulair for Children January 23, 2009

Institute for Safe Medication Practices QuarterWatch: 2008 Q2 Jan 15, 2009
In the second quarter...[FDA Adverse Event] reports of serious injuries for the asthma drug montelukast (Singulair) among children and adults grew seven-fold... montelukast accounted for more possible cases of depression/suicidal behavior, hostility/aggression and psychosis than any other prescription drug...644 serious, disabling or fatal injury cases identified montelukast as the principal suspect drug, including 26 reported patient deaths with 8 in children under 18 years of age.

Singulair and Depression eMedTV, January 15, 2009
Depresion was reported as an adverse event in the clinical trials for Singulair.

FDA Finds No Link So Far Between Asthma Drugs and Suicide Risk, Amanda Gardiner, Health Day, January 14, 2009. "We have finished our analyses of all the data the companies submitted," FDA spokeswoman Karen Riley told the Associated Press. "But that doesn't mean we have closed the book on suicidality."

FDA Update of Safety Review: Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) January 13, 2009

FDA probe finds no link with asthma drugs, suicide, Matthew Perrone, Associated Press, January 13, 2009.  "Federal health officials said Tuesday that asthma drugs, including Merck's Singulair, do not appear tied to suicide - though regulators continue to examine possible links to behavioral problems."

Merck Statement In Response To The FDA's Update Regarding A Safety Review Of SINGULAIR (montelukast) 

Boy's mom thinks Singulair sales should be suspended during probe KY3 News Cara Restelli, KY3 News, October 2, 2008

WBZTV Reports on Singulair

If Prescription Meds Don't Kill You They Might Drive Your Crazy Douglas Bremner, M.D. explains a mechanism by which Singulair may cause depression.

FDA Probing Possible Link Between Asthma Drug and Suicide Risk Amanda Gardner HealthDay March 2008