| Posted at 9:35 AM on Jan 15, 2009 by froglover1069, #38043 |
No No No, this is NOT true. Read the FDA statement here:
http://www.fda.gov/Cder/drug/early_comm/montelukast_200901.htm
It states that: "Although these data do not suggest that montelukast, zafirlukast, or zileuton are associated with suicide or suicidal behavior, these clinical trials were not designed specifically to examine neuropsychiatric events. As a result, some events may not have been reported."
It also states that "Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribers should monitor for the possibility of neuropsychiatric events associated with these agents."
It is not over - the FDA is continuing to investigate!!!!
Also read this:http://www.ismp.org/quarterwatch/200901.pdf
fro the Institute of Safe Medication Practices
"In the second quarter... 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."
"In the past, drug manufacturers have sought to discount spikes in adverse event case reporting when connected to publicity as “stimulated” reporting, as if the cases were somehow less valid than other reports. We believe the opposite: without patients and doctors getting adequate information about possible drug adverse events, the injuries caused by drug therapy will be substantially underreported in any kind of monitoring system. Rather than discounting these events, such spikes are evidence of the system
beginning to correct undercounting that routinely occurs."
COMPLAIN TO YOUR LOCAL NEWS AND SEND THEM THIS IMPORTANT INFORMATION!!!!!!!!!!!
I know zsmom, that is why I was so shocked. I'm just relaying what the new reported. I've been a part of this thread for a very long time. I'm just saying that I was shocked that the ****news reported no link between singulair and suicide****
Oh good I'm glad you knew. So many people thought it was over - I didn't want you to think so too - especially since you've been part of this longer than I. I wasn't attacking you with my emphatic reply. That was directed toward the misleading headlines and partial news stories that omit the most important information. Sorry if I offended - not my intention at all!
merck suicide fda safe medication practices adverse event reporting system fda statement patient deaths asthma drug zileuton montelukast clinical details quarter reports zafirlukast time patients leukotriene suicidal behavior prescribers drug manufacturers cder singulair paucity psychosis hostility long time misleading headlines important information news stories intention reply