Have a question?
Contact us with your questions about this information.
Singulair (Montelukast Sodium) And Suicide, Suicidal Ideation And Other Serious Adverse Events
Thornton & Naumes is currently investigating reports that Singulair may be associated with suicide, suicidal ideation or other serious neuropsychiatric adverse events.
Singulair (montelukast sodium) is an allergy drug indicated in the treatment of asthma attacks and exercise-induced bronchoconstriction in adult patients suffering from chronic asthma and in children twelve months and older. Singulair belongs to a group of drugs known as leukotriene inhibitors. Leukotrienes are chemicals in the body that are released when we encounter certain naturally occurring allergens. Singulair was first approved for use in the U.S. by the FDA in 1998.
In 2007 Merck & Co., Inc., the maker of Singulair, updated the patient information sheet several times over the course of the year to include information on Singulair and other related symptoms. There were updates for tremor in March 2007, depression in April 2007, and suicidal thinking/behavior in October 2007. In February of 2008, Merck & Co. updated the drug information sheet to include information on Singulair and symptoms of anxiousness.
In March of 2008, the Food and Drug Administration (FDA) issued an early communication (http://www.fda.gov/cder/drug/early_comm/montelukast.htm) stating it had initiated a safety review of Singulair due to reports of the use of this medication and attempted and completed suicides. The FDA received reports of suicides, suicidal ideation, and changes in mood in patients on Singulair, and began a safety review on that basis.
On January 13, 2009, the FDA issued a statement noting that after review of Merck clinical trials of Singulair, no association was found between Singulair and suicide or suicidal ideation. FDA also noted that:
"Although these data do not suggest that montelukast…… 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." http://www.fda.gov/cder/drug/early_comm/montelukast_200901.htm
The statement also noted that the Agency was continuing to review clinical trial data to assess other neuropsychiatric events, and would report those results in the future.
Of note, FDA reported that post-marketing reports (reports of events received after Singulair was on the market) of neuropsychiatric events had been received by the Agency's Adverse Event Reporting system:
"Post-marketing reports of neuropsychiatric events associated with montelukast … 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 [other leukotriene pathway drugs], 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."
This finding by FDA of a possible drug induced effect related to montelukast (Singulair) is supported by a review of the Adverse Events reported to FDA by the Institute for Safe Medication Practices (ISMP) (http://www.ismp.org/QuarterWatch/200901.pdf) which recently released its QuarterWatch report for the 2nd Quarter of 2008. The ISMP looked at adverse events reported for Singulair, and noted that in the period reported on, FDA received 644 serious, disabling or fatal injury cases identifying Singulair as the primary suspect drug. The ISMB attributed the rise in reported events partly to the publication of FDA's Early Communication in March of 2008 http://www.fda.gov/cder/drug/early_comm/montelukast.htm and wrote:
"The results further indicate an effect of the FDA Early Communication. The agency had received 24 cases (4/%) of possible psychiatric side effects before the warning, and 602 cases (96%) after the warning."
Significantly, on the issue of whether Singulair could be associated with neuropsychiatric events, ISMP concluded that:
"The case for a possible causal relationship was strengthened by the 204 cases in which the reporter said that the psychiatric adverse effect went away once drug treatment was halted. In another 40 cases, the psychiatric side effect reappeared once the drug was started again." The ISMB also found that children accounted for 67% of potential psychiatric adverse side effects reported.
If you or a loved one has been injured by Singulair, please contact Thornton & Naumes by phone at our toll-free number: 1-800-431-4600 or email attorney Marilyn McGoldrick at mmcgoldrick@tenlaw.com for more information.