But I am not going to recommend to my patients that they stop using Singulair. That would be stupid and irresponsible. Asthma kills. It does long-term damage. To lots and lots of people with asthma.
And Singulair, for those patients who need it, works.
Here’s my presentation for tomorrow morning’s rounds:
The USFDA announced Thursday that it was investigating the possibility of a link between mood changes, anxiety, and increased suicide amongst patients taking the asthma medication Singulair (montelukast). The other leukotriene receptor antagonists Zyflo and Accolate are reportedly also under investigation. Health Canada is following suit.
Merck officials state that the investigation is based on three or four reported suicides since October 2007. They point out that no suicides have been noted in any of the previous studies, though it is not clear whether this was an endpoint that was recorded.
Safety profiles for most drugs are not complete until several years into post-marketing research, due to the fact that some effects are vanishingly rare and would require huge numbers of subjects/patients to be analysed before they come to light. This is particularly the case for unanticipated events, like suicidal thoughts from an asthma medication.
Word from the FDA is:
“Singulair is an effective medicine that is indicated for the treatment of asthma … Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.”
Health Canada has not recommended that Singulair be discontinued.
Baseline age-adjusted suicide rates in the US are 11.1/100 000; slightly higher in Canada. Merck reports sales of $4.3 billion from Singulair.
Leukotriene receptor antagonists are second-line maintenance therapy for use as an add-on when inhaled corticosteroids do not provide adequate control. They are generally well-tolerated and the most-common side effects are headache, URI, abdominal pain, cough, and dyspepsia. All that said, there is still no mention of suicidal thoughts, behaviour, or completed suicide in the safety profle on Merck’s website.
The ambulance chasers have, however, already set up at least one website.