Recent News about Singulair

The Food and Drug Administration (FDA) released an updated safety review, indicating data submitted by Merck, AstraZeneca and Cornerstone Therapeutics do not suggest that montelukast, zafirlukast nor zileuton are associated with suicide or suicidal behavior.

Previous March the FDA said it would conduct a 9-month review of safety data of the three drugs due to concerns about a possible association between the use of montelukast and mood changes, suicidal thinking/behavior and suicide.

Data from almost 20,000 patients enrolled in clinical trials with the three leukotriene modifiers were reviewed by the FDA. No specific association was found with the use of these drugs to suicidal ideation or completed suicide. However, these clinical trials were not designed specifically to examine neuropsychiatric events, and as a result, some events may not have been reported.

Post-marketing reports of neuropsychiatric events associated with the three drugs were reported to FDA’s Adverse Event Reporting System (AERS). The FDA acknowledges that because of the paucity of the reports, assessment of a drug-induced effect with these is limited.

Today, the Institute for Safe Medication Practices (ISMP) released a report based on AERS data titled “QuarterWatch: 2008 Quarter 2,” indicating reports of serious injuries among children and adults on Montelukast grew seven-fold in the quarter following an FDA public notice that it was studying a possible link between the drug and aggressive and suicidal behavior.

The ISMP report notes “By alerting parents and patients to the possibility that these adverse effects could occur, the notice spurred large numbers of reports to the FDA and the drug’s manufacturer, Merck & Co. Prior to the FDA notice similar reports had been received but they were small in number. These reports provide a clear signal that further investigation is required to establish or rule out a direct causal relationship.”

Currently, the FDA is continuing to review clinical trial data to assess other neuropsychiatric events related to drugs that act through the leukotriene pathway, but has not yet reached a definitive conclusion, which may take months to complete.

The College’s recommendations to our members for guidance they can provide to their patients and the media remain the same as in our previous statement: based upon information currently available, patients taking leukotriene modifiers should continue taking the medication; however as with all medications, it is important to carefully monitor use and to discuss any adverse events.
* on-line at [www.fda.gov/medwatch/report.htm];
* by returning the postage-paid FDA form 3500 [available in PDF format at [www.fda.gov/medwatch/getforms.htm] to 5600 Fishers Lane, Rockville, MD 20852-9787;
* faxing the form to 1-800-FDA-0178; or
* by phone at 1-800-332-1088