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Terbinafine: tolerability in general medical practice.
1Novartis Pharmaceuticals UK Ltd, Frimley, Surrey. des.osullivan@pharma.Novartis.com
The British Journal of Dermatology
|March 24, 2000
Summary
Terbinafine demonstrates excellent tolerability in over 25,000 patients across general medical practice. Most patients experienced no adverse events, confirming its safety profile for treating conditions like onychomycosis.
Area of Science:
- Dermatology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Terbinafine is an established antifungal medication.
- Postmarketing surveillance is crucial for assessing drug safety in real-world settings.
Purpose of the Study:
- To evaluate the tolerability of terbinafine in a large, unselected patient population within general medical practice.
- To assess adverse events and drug interactions associated with terbinafine use.
Main Methods:
- Four prospective, open-label, postmarketing studies were conducted across four European countries.
- Over 25,000 patients receiving terbinafine were monitored for adverse events.
- Data collection included baseline, during treatment, and end-of-treatment assessments.
Main Results:
- 89.5% of patients reported no adverse events.
- The most common adverse events were gastrointestinal (4.9%) and dermatological (2.3%).
- No clinically significant drug-drug or drug-disease interactions were observed.
Conclusions:
- Terbinafine is well tolerated in a broad, unselected patient population in general practice.
- These findings support the safety profile of terbinafine established in controlled clinical trials.
- The drug is suitable for widespread use in managing conditions like onychomycosis.