Health trends - Update on safety of SINGULAIR
Published: Wednesday | February 11, 2009
Merck & Co, Inc issued the following statement in response to the US Food & Drug Administration's (FDA's) update on its safety review of SINGULAIR (montelukast). Merck stands by the proven efficacy and safety of SINGULAIR, a medicine that has been prescribed to tens of millions of patients with asthma and allergic rhinitis for more than 10 years. Nothing is more important to Merck than the safety of its medicines and vaccines.
Since distribution of the 'FDA Early Communication of an Ongoing Safety Review of Monelukast' on March 27, 2008, the FDA requested that Merck conduct additional evaluations of the data from clinical trials of SINGULAIR for reports of behaviour and mood changes, and for reports of suicidality and suicide.
Preparing to publish
Merck has submitted the information requested by the agency and is preparing to publish the data in a peer-reviewed medical journal. Merck also continually reviews post-marketing reports as part of its ongoing commitment to monitor the safety profile of its medications.
After a thorough review of the data from the controlled clinical trials of SINGULAIR, and a careful assessment of post-marketing adverse events, Merck believes that the data support the continued use of SINGULAIR in appropriate patients with asthma and allergic rhinitis. Merck agrees with the FDA's statement that the data from clinical trials do not suggest that SINGULAIR is associated with suicide or suicidal behaviour, although these clinical trials were not designed specifically to examine neuropsychiatric events.
Adjudicated event
In the suicidality analysis submitted to the FDA, which included 9,929 patients who received SINGULAIR and 7,780 patients who received placebo, there was one adjudicated event of suicidal ideation in one patient (an adult treated with SINGULAIR). There were no completed suicides, suicide attempts or preparatory acts towards suicidal behaviour in the group who received SINGULAIR or the group who received placebo.
In the behaviour and mood change analysis, which included 11,673 patients who received SINGULAIR and 8,827 patients who received placebo, the incidence of patients with at least one behaviour-related adverse experiences (BRAE) was 2.73 per cent and 2.27 per cent in the SINGULAIR and placebo groups, respectively. The FDA is continuing to review these clinical trial data.
Source: Merck & Co, Inc