Postmarketing surveillance of oral terbinafine in the UK: report of a large cohort study

Abstract

1. The safety profile of terbinafine, the first orally active allylamine, was monitored in the UK in a post-marketing setting. The study recruited 10,361 patients, a number which is approximately 5% of the population who received oral terbinafine in the UK during the period of the study. 2. Follow-up data were available on 9,879 patients. During the course of the study 14.5% patients reported medical events. 49% were thought to be possibly or probably related to terbinafine treatment. Seventy-four of the events (< 1%) were classified as 'serious' and of these only five were assessed as possibly or probably related to treatment. 3. Taste disturbance occurred in 0.6% of the patients and emerged as the only new adverse reaction probably attributable to terbinafine: this was significantly commoner in females and reversible on stopping treatment, with a median time to recovery of 42 days. 4. The study approach successfully combined hospital based dermatology outpatient and general practice centres. Source data verification was conducted on 13% of the cohort selected randomly. 5. Overall, the denominator-based description of the safety profile in actual practice shows terbinafine to be well-tolerated against a wide background of age and coexisting illness.

Lack of Awareness of the Impact of Improperly Disposed Of Medications and Associated Factors: A Cross-Sectional Survey in Indonesian Households

“…Counseled patients were more likely to properly return unused medications to pharmacies and healthcare providers (Seehusen and Edwards, 2006). Moreover, previous studies in the United Kingdom and Sweden showed that information campaigns to increase awareness resulted in a higher rate of returning medications to pharmacies (O'Sullivan et al, 1996;Persson et al, 2009). To our knowledge, this is the first thorough evaluation of factors associated with lack of public awareness of proper disposal of unused medications and the associations between the individuals' awareness and their actual medication disposal practices among Indonesian respondents.…”

Possible exercised-induced rhabdomyolysis associated with terbinafine

“…Terbinafine is a medication used for the treatment of onychomycosis [1]. Postmarketing surveillance of terbinafine found uncommon nonspecific musculoskeletal complaints [2, 3]. Rhabdomyolysis is recognized as an adverse effect of terbinafine without a specific frequency in product documentation [4].…”

Antifungal Selection for the Treatment of Onychomycosis: Patient Considerations and Outcomes

“…74 In a post-marketing survey of 10,361 onychomycosis patients treated with oral terbinafine, reversible taste disturbances were reported in 0.6% of patients, with a mean taste recovery time of 42 days (range 2-186 days). 75 A case-control study of 87 patients with terbinafine-induced taste loss and 362 controls taking terbinafine without taste loss identified low body mass index (BMI) (RR: 12.8, 95% CI 1.9-88.6), a history of taste loss (P<0.007), and older age (RR: 4.4, 95% CI 1.4-16.1) as risk factors. 76 The mechanism of terbinafine associated hepatotoxicity is not fully understood, though one hypothesis posits that terbinafine metabolites bind to hepatobiliary proteins, inducing an immune reaction.…”