March 27, 2008 - Merck & Co., Inc. issued the following statement in response to the FDA Early Communication of an Ongoing Safety Review of Montelukast (SINGULAIR™) that was posted today on the FDA website. SINGULAIR has been marketed in the US for 10 years and millions of patients have been prescribed SINGULAIR in the US and around the world. Merck voluntarily updated the worldwide product label for SINGULAIR in October 2007 to include "suicidal thinking and behavior" and included similar changes to the patient product information. These actions were based on a very limited number of post-marketing adverse event reports that Merck has received. Since that time, Merck has worked with the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians.
Information from post-marketing reports is incorporated by Merck into the product label and patient product information as appropriate to help inform healthcare practitioners and patients. The fact that an adverse event has been reported to Merck and to regulatory agencies does not reflect a conclusion that the post-marketing event is caused by SINGULAIR. In general, a post-marketing adverse event may be caused by underlying disease, genetic condition, the medication, concomitant medications or background event that may occur in any population... Merck's Press Release -
