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Leukotriene inhibitors found not to be associated with suicide among children

The use of leukotriene receptor-modifying agents for asthma treatment was not associated with an increased risk for suicide in children, according to new study results.

“This study should give patients and clinicians assurance about the safety of these drugs with regard to suicide, especially in children 5 to 19 years old,” study researcher Glen T. Schumock, PharmD, MBA, PhD, told Healio.com. “It is this age group who may benefit from [leukotriene-modifying agents] because they are taken orally, whereas many other asthma medications are inhaled, which may be difficult for children.”

The FDA has issued safety alerts about the possible link between leukotriene-modifying agents (LTMAs) and suicidality and suicide, and requested that manufacturers include a precaution in LTMA drug labeling. Because the alerts were based on case reports, Schumock, of the University of Illinois, and colleagues conducted a nested case-control study to determine the association between LTMAs and attempted suicide among asthmatic children and young adults.

The researchers analyzed data obtained from an insurance claims database that included a nationally representative sample of 344 asthmatic patients and 3,438 matched control individuals aged 5 to 24 years. The researchers performed conditional logistic regression analyses to determine the link between LTMA exposure and risks for attempted suicide.

Among case patients, 5.52% were using LTMAs at the time of the suicide attempt vs. 6.52% of those in the control group (OR=0.80; 95% CI, 0.49-1.31). The researchers found that current use of any LTMA was not associated with increased risk for suicide attempts, and, in fact, the direction of effect was the opposite, with a 30% reduction in the odds of suicide attempts in those using LTMAs (adjusted OR=0.70; 95% CI, 0.36-1.39). Results also showed no association between the cumulative dose of LTMA and suicide attempts.

In stratified analyses, the researchers initially found a statistically significant increased risk for suicide (AOR=5.15; 95% CI, 1.16-22.86) in patients aged 19 to 24 years — an age group with an overall higher prevalence of risk factors for suicide, including past suicide attempts, psychiatric disorders and other diseases associated with suicide, greater exposure to medications known to increase suicide risk and more severe asthma. After adjusting for previous exposure to other asthma medications and other drugs associated with suicide, the result was no longer statistically significant (AOR=5.64; 95% CI, 0.87-36.66).

“We did find exploratory evidence that the association between LTMAs and [suicide attempts] might vary by age group, with potentially increased risk in those 19 to 24 years of age,” the researchers wrote. “Further research needs to be conducted to more fully understand the association between LTMAs and suicide, particularly in subgroups by age (including adults).”

Disclosure: Study researcher Todd A. Lee, PharmD, PhD, is a consultant for Merck and Forest Pharmaceuticals and has received research support from Novartis. The rest of the researchers report not relevant financial disclosures.