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

Abstract

1. A 1 in 200 sample of the Southampton electorate were sent a postal questionnaire in January 1993. Of the 756 adults surveyed, 400 (52.9%) returned completed questionnaires. One hundred and eighty-eight (47.0%) of the respondents had been prescribed a medicine within the previous month. 2. Compared with a survey 9 years earlier, medicine taking had increased amongst men (44.1% vs 33.7% NS) and drugs acting on the respiratory system were in more widespread use (19 vs 7 patients P < 0.05). 3. Patterns of storage of medicines were almost identical to those found in 1984. However, methods of disposal were significantly different with 34% of the respondents stating that they would return left-over medicines to the Doctor or Pharmacist compared with 17% in the previous study (P < 0.01). 4. Of those taking medicines 120 (63.8%) had received a manufacturers' information leaflet. Medicines used to treat disorders of the respiratory and cardiovascular systems were most likely to be accompanied by such a leaflet (74% and 70% respectively). 5. Those who received a leaflet were almost all satisfied by it. However, patient awareness of potential side effects remained poor with only 30% being aware of any which their medicine might cause. 6. Despite improvements in attitudes towards medicine taking over time patients awareness of potential adverse effects remains limited. Further research is necessary in order to determine how best to educate patients on this topic.

Serious Adverse Events Reporting on Systemic Terbinafine: A Danish Register-based Study

“…The result shows that the high number of SAE-cases in the second half of the observed period could be explained by an increase in consumption of terbinafine. Safety reports from clinical trials, as well as surveillance studies, have proven good safety records for terbinafine (5)(6)(7). In our study, hepatobiliary disorders and the category "Investigations", which mostly covered an increase in liver enzymes, were among the three most prevalent SAEs reported, indicating a potential risk of hepatic dysfunction in the use of terbinafine.…”

Safety of Oral Terbinafine

“…In the population of 25 884 patients, only 10.5% experienced an adverse event of any type or cause. Slightly more than half of all adverse events were consid¬ ered by the investigator to be possibly or probably related to terbinafine, and these conform to the known safety pro¬ file of the drug.…”

Guidelines for the management of tinea capitis

“…Side‐effects include; gastrointestinal disturbances and rashes in 5% and 3% of cases, respectively. 21 ( Strength of recommendation = A/B; quality of evidence = I/IIi . )…”