Adverse drug reactions of montelukast and pranlukast: Analysis of the Korea database
Eun-Yong Shin,1,2 Ju-Hae Jin,1 Min-Kyoung Kang,2 Young-Sang Yoo,1,2 Ji-Hyang Lee,1,2 Woo-Jung Song,1,2 Hyouk-Soo Kwon,1,2 You Sook Cho,1,2 Hee-Bom Moon,1,2 Tae-Bum Kim1,2
1 Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
2 Pharmacovigilance Center, Asan Medical Center, Seoul, Republic of Korea
Abstract
Background: Leukotriene receptor antagonists are recommended to treat asthma and allergic rhinitis. Although they had been used for a long time, recent studies have reported neuropsychiatric adverse drug reactions are associated with montelukast.
Objective: This study analyzed the adverse drug reactions of montelukast and pranlukast, which are the two most frequently prescribed leukotriene receptor antagonists, respectively in Korea.
Methods: This study retrospectively reviewed ADRs of 5,426 montelukast and 1,146 pranlukast reported in the Korea Adverse Event Reporting System between January 2014 and December 2018.
Results: When both drugs are classified by system organ class, the most adverse drug reactions were related to the gastro-intestinal system, followed by psychiatric events. The reported adverse drug reactions for both drugs were more common in women, and the ratio of adverse drug reactions to prescriptions was highest in the elderly. Women aged 19 to 64 years reported more than twice as many adverse drug reactions than men of the same age, and more than 5 times in insomnia.
Conclusions: When prescribing montelukast and pranlukast, attention would need to digestive and sleep disorders, especially women aged 19 to 64. After prescribing montelukast, physicians would need to pay more attention to agitation (5/396378 vs 0/82475), bad or vivid dreams (6/396378 vs 0/82475), anxiety (11/396378 vs 0/82475), depression (14/396378 vs 1/82475), tremor (53/396378 vs 7/82475), irritability (5/396378 vs 1/82475), insomnia (159/396378 vs 25/82475), and headache (68/396378 vs 10/82475), compared to when prescribing pranlukast. Further prospective research needs to elucidate the relationship between neuropsychiatric events and montelukast.
Key words: Leukotriene receptor antagonist, sleep disorder, neuropsychiatric events, insomnia, depression