Safety of oral terbinafine: results of a postmarketing surveillance study in 25,884 patients.
OBJECTIVE
To broaden the safety database for oral terbinafine by determining the incidence of adverse events, particularly rare risks, that accompany its uncontrolled use in actual clinical practice.


METHODS
Four open, prospective, uncontrolled, postmarketing surveillance studies were conducted in unselected patients in 4 countries. No exclusion criteria were applied. The only treatment instructions participating physicians received were the manufacturer's product information. Physicians monitored patients for adverse events at baseline, during treatment, and at the end of treatment. Serious events were identified according to study protocol, which was consistent for all 4 studies, allowing data to be pooled and analyzed collectively.


METHODS
Patients were recruited from dermatology, general, and family practices in the United Kingdom, the Netherlands, Germany, and Austria.


METHODS
Of the 25884 patients who entered the study, 38.6% had concomitant diseases, 42.8% were taking other medications, and 22.7% were older than 60 years. The predominant indication for terbinafine treatment was onychomycosis (72.2%).


METHODS
Data on treatment duration was available for 25091 patients. Median duration of treatment was 12 weeks (mean, 13.2 weeks). Treatment extended beyond 6 weeks in 76.0% of patients and for at least 12 weeks in 59.3%.


METHODS
The incidence of adverse events as reported by physicians, with their opinions regarding relationship to terbinafine therapy.


RESULTS
The incidence of adverse events was 10.5%; the majority involved the gastrointestinal system (4.9%) or skin (2.3%). These tended to be mild, transient, and reversible. Terbinafine was considered a possible or probable cause of 11 (0.04%) serious adverse events. No drug interactions were reported, even in patients taking oral antidiabetic agents, astemizole, terfenadine, or cimetidine hydrochloride.


CONCLUSIONS
The positive safety profile established during controlled clinical trials of oral terbinafine extends to its uncontrolled use in clinical practice. No previously unrecognized risks were identified.
Hall
M
M
Clinical Research-Dermatology/Immunology, Novartis (formerly Sandoz) Pharmaceuticals Corporation, East Hanover, NJ 07936, USA.
Monka
C
C
Krupp
P
P
O'Sullivan
D
D
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D018849:Controlled Clinical Trials as Topic; D019992:Databases as Topic; D004064:Digestive System / Q000187:drug effects; D004194:Disease; D004347:Drug Interactions; D016903:Drug Monitoring; D004358:Drug Therapy; D005060:Europe; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects* / Q000627:therapeutic use; D014009:Onychomycosis / Q000188:drug therapy; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012307:Risk Factors; D012449:Safety; D012867:Skin / Q000187:drug effects; D000077291:Terbinafine
D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine