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Thursday, August 17 2017
Press release

Anti-asthma treatment linked to neuropsychiatric side effects

Pharmacovigilance necessary to identify patients at risk

MONTRÉAL, August 17, 2017 – Approximately 16% of asthmatic children have stopped their montelukast treatment due to important neuropsychiatric side effects, according to a new study conducted by researchers at CHU Sainte-Justine and the Université de Montréal, published in the European Respiratory Journal. Even though the medication is generally well tolerated, previous post-marketing studies have reported adverse effects on mood and behaviour, such as irritability, aggressivity, and sleep disorders, in some patients. However, very little data was available on the incidence of side effects severe enough to require stopping the medication.

The study concerned a cohort of 106 asthmatic children from 1 to 17 years of age, who had been initiated to montelukast, also known by the name of Singulair®, a medication used in the treatment of asthma as a substitute for, or in addition to, inhaled corticosteroids (ICS). The cohort was matched to a control cohort of children treated only with ICS. "The parents were interviewed with a standardised questionnaire to verify whether their child had experienced side effects with any asthma medication and, if so, asking them to identify which medications and the circumstances related to the event," Dr. Francine M. Ducharme, pediatrician and principal author of the study, explains. "We also gathered data regarding the type of symptoms, the delay in the onset of the adverse reactions, the time between stopping the medication and resolution of the problem, the reappearance of adverse reactions if the medication was resumed, and risk factors, such as personal and family medical conditions." After analyzing the data, the research team recognized that approximately 1 out of 6 children (16%) treated with montelukast had experienced neuropsychiatric side effects leading them to stop their medication, generally within 14 days of the beginning of treatment.

Montelukast ranks 8th among the medications most commonly used by Canadian children and 3rd among the most prescribed asthma medications, after salbutamol inhalers (e.g.: Ventolin®) and certain ICSs. "It is essential to inform parents and healthcare professionals about the importance of remaining vigilant for any change in behaviour or appearance of sleep disorders in the days following the start of treatment. They should consider that montelukast may be related to these changes," warns Denis Lebel, pharmacist and Pharmacovigilance Officer at CHU Sainte-Justine. "We suggest a close observation period between 2 and 4 weeks."

To date, stopping the medication is the key medical recommendation in case of such side effects. The best way to confirm a cause-and-effect relationship is by observing the disappearance of symptoms after the medication is stopped and a resumption of symptoms after its reintroduction. "Knowing that the average time for symptoms to disappear is 2 days if the treatment is stopped rapidly, if the change of behaviour persists after its cessation or does not resume after the reintroduction of the medication, we need to consider that these symptoms may be due instead to another event in the child's life, such as school or family difficulties," Dr. Ducharme adds.

Asthma is the most frequent chronic disease in children, affecting between 10% and 15% of Canadian children.  Montelukast remains an excellent second-line medication and should not be abandoned without a valid reason.  "We do not know the factors that predispose some children to experience adverse reactions, but we believe there may be a genetic component. This accounts for the interest in pursuing our research," Dr. Ducharme concludes.

About the study

The article "Benard B, Bastien V, Vinet B, et al. Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice. Eur Respir J 2017; 50: 1700148" was published online in the European Respiratory Journal on August 17, 2017. The first author is Brigitte Bénard, a medical student at the Université de Montréal. The lead author is Dr. Francine Ducharme, Director of the Asthma Clinic and Researcher at CHU Sainte-Justine, and Professor in the Department of Pediatrics and the Department of Social and Preventive Medicine of the Université de Montréal. This Study was conducted by the Clinical Research and Knowledge Transfer Unit on Childhood Asthma (RECAP) of the CHU Sainte-Justine Research Center and was made possible by the collaboration of many parents of asthmatic children followed at the Asthma Clinic of CHU Sainte-Justine. This study was funded by donations, which allowed the creation of the Pediatric Chair of Clinical Research and Knowledge Transfer on Childhood Asthma of CHU Sainte-Justine. Students Valérie Bastien and Brigitte Bénard also received financing support from the PREMIER program of the Fonds de recherche du Québec – Santé (FRQS) and the above-mentioned Chair.

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About the CHU Sainte-Justine Research Center

CHU Sainte-Justine Research Center is a leading mother-child research institution affiliated with Université de Montréal. It brings together more than 200 research investigators, including over 90 clinician-scientists, as well as 450 graduate and postgraduate students focused on finding innovative prevention means, faster and less invasive treatments, as well as personalized approaches to medicine. The Center is part of CHU Sainte-Justine, which is the largest mother-child centre in Canada and second pediatric center in North America. More on research.chusj.org

About CHU Sainte-Justine

The Sainte-Justine university hospital centre (CHU Sainte-Justine) is the largest mother-child centre in Canada and the second largest pediatric hospital in North America. A member of the Université de Montréal extended network of excellence in health (RUIS), Sainte-Justine has 5,457 employees, including 1,532 nurses and nursing assistants; 1,000 other healthcare professionals; 520 physicians, dentists and pharmacists; 822 residents; and 204 researchers, 411 volunteers and 4,416 interns and students in a wide range of disciplines. Sainte-Justine has 484 beds, including 67 at the Centre de réadaptation Marie Enfant, the only exclusively pediatric rehabilitation centre in Quebec. The World Health Organization has recognized CHU Sainte-Justine as a “health promoting hospital.” chusj.org


CHU Sainte-Justine

Maude Hoffmann
Communications, CHU Sainte-Justine Research Center

Media contact:
Mélanie Dallaire
Executive advisor – External communications
CHU Sainte-Justine
Office: 514-345-7707 / Pager: 514-415-5727


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