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.
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.
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 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."
