Risk of toxic epidermal necrolysis and Stevens-Johnson syndrome associated with benzodiazepines: a population-based cohort study

Abstract

The incidence of SJS/TEN in tetrazepam users was very rare and similar to benzodiazepines users. The incidence in the GenPop and among users of phenytoin agreed with the literature.

Validation of Stevens-Johnson syndrome or toxic epidermal necrolysis diagnoses in the Clinical Practice Research Datalink

“…Our calculated overall IR of 6.52 cases/million person‐years is consistent with previously reported IRs for SJS/TEN, which ranged between 1 and 12.7 cases/million person‐years . This further corroborates the validity of our final study population, although the range of previously reported IRs is wide, likely because of difficulties in defining patients at risk, different case definition, or because of absence of certain triggering drugs on the market during earlier study periods.…”

“…These reactions are rare, with estimated incidence rates (IR) of SJS/TEN ranging from 1 to 12.7 per million person-years. [1][2][3][4] Current evidence suggests that SJS and TEN are one disease entity, which differ by the proportion of body surface area affected by skin detachment. [5][6][7] Epidemiologic data on SJS/TEN is limited; previous studies have focused primarily on identifying drugs that cause these skin reactions using hospital based case-control studies.…”

Active surveillance of severe cutaneous adverse reactions: A case‐population approach using a registry and a health care database

“…Also, the Expert Committee established the index date by examining the sequence of clinical events. Both are clear advantages over those studies using electronic databases for the detection of cases . Secondly, the control series was randomly sampled from BIFAP which in turn represents a large and fairly representative sample of Madrid population, preventing from a selection bias described for hospital‐based controls .…”

“…The advantage of our approach is that we estimated directly the number of new users in the base population. Other authors applied the new user concept using electronic databases, but the main limitation of databases, as previously discussed, is the ascertainment of valid cases (most of them without access to a full clinical description, pictures of skin lesions, and histopathological results), as well as the uncertainty in setting an appropriate index date. Finally, our approach has the advantage over other case‐population studies that we were able to capture information on potential confounders for both cases and controls and adjust for them.…”

“…Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP, version 2016) is a database of anonymised electronic health records belonging to patients seen in general practices from Madrid (around 2.4 million patients) and eight other regions (around 5.6 million patients) . BIFAP includes information on patient demographics, prescription and dispensation details, clinical events (coded using either ICPC medical terms dictionary or ICD‐9, depending on the autonomous community), free text comments entered by physicians, referrals, and laboratory test results, as fully described elsewhere . Population in BIFAP has a distribution by sex and age comparable to the Spanish population…”