Intranasally administered corticosteroids and neuropsychiatric disturbances: a review of the international pharmacovigilance programme of the World Health Organization.
BACKGROUND
The systemic use of corticosteroids is connected with a variety of psychiatric and neurologic effects. Corticosteroids for intranasal administration (INCs) are considered to act locally and to exert minimal systemic effects. An unexpected cluster of case reports of neuropsychiatric disorders during intranasal corticosteroid use was reported to the World Health Organization Uppsala Monitoring Centre.


OBJECTIVE
To investigate the possible connection between intranasal corticosteroid use and the development of neuropsychiatric disorders, as reported to the International Pharmacovigilance Programme.


METHODS
All reports containing adverse event terms indicating neuropsychiatric disturbances in suspected connection with intranasal corticosteroids were retrieved from Vigibase and evaluated (April 2006). The case reports are heterogeneous and vary regarding source, documentation quality, and relationship likelihood.


RESULTS
A total of 429 reports were received from 16 countries (1980-April 2006), of neuropsychiatric events occurring in patients using INCs, representing 7.6% of the total of reports regarding these drugs in the same period. Frequently reported events were nervousness, anxiety, agitation, insomnia, emotional lability, depression, somnolence, confusion, convulsions, and migraine. Most reports concerned fluticasone propionate, beclometasone dipropionate, mometasone furoate, or budesonide. In 370 reports (86.2%), the INC was the sole suspect drug and in 220 (51.3%) it was the only drug used. In 97 of 108 patients who had discontinued use of the intranasal corticosteroid, the reaction abated. Of 41 patients, 32 had a relapse when the drug was reintroduced.


CONCLUSIONS
The data collected by the International Pharmacovigilance Programme suggest that the intranasal use of corticosteroids can be complicated by neuropsychiatric adverse reactions. Further study is needed to confirm the connection and to determine the frequency and risk factors of such reactions.
Pokladnikova
Jitka
J
Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, Czech Republic. jitka.pokladnikova@faf.cuni.cz
Meyboom
Ronald H B
RH
Vlcek
Jiri
J
Edwards
Ralph I
RI
D000281:Administration, Intranasal; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects*; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced*; D009422:Nervous System Diseases / Q000139:chemically induced*; D014944:World Health Organization
D000305:Adrenal Cortex Hormones