Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017

Abstract

Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions (SCARs). There is scant literature on the characteristics and causes of these conditions among the Nigerian population. Here, we describe the epidemiology, associated morbidity and mortality, and culpable drugs in SJS and TEN cases using the National Pharmacovigilance (NPC) database in Nigeria. Methods: A retrospective review of the NPC database was done to analyze SJS and TEN cases reported over a period of 14 years. Annual reports, age and sex of patients, type of reporter, suspects and concomitant drugs, time to onset (TTO) of the reactions, and outcome of SJS and TEN were evaluated. Results: The NPC received a total of 24,015 adverse drug reaction (ADR) reports. SJS and TEN accounted for 284 (0.1%) of the total reports, of which 254 (89.4%) were SJS and the remainder were TEN. Females ( n = 184, 64.8%) and individuals aged 19–40 years ( n = 181, 63.7%) were the most affected by SJS and TEN. Antiretrovirals, followed by antibiotics, were the most common drug classes reported to cause SJS and TEN, with nevirapine ( n = 174, 40.7%) and co-trimoxazole ( n = 143, 33.5%) being the most widely implicated drugs. Among patients with reported outcomes, 73 (28.7%) SJS and 3 (10.0%) TEN cases recovered without sequelae, at the time of reporting. Severity of the SCAR was reported for only 171 (69.0%) cases, of which 12 (4.7%) and 8 (26.7%) resulted in death (Grade 5) among SJS and TEN cases, respectively. Conclusions: Antiretroviral and antibiotics were the commonly reported offending group of drugs for SJS and TEN cases. Nevirapine and co-trimoxazole were the commonly reported suspect drugs. SJS and TEN were reported most frequently in females and in patients aged 19–40 years, indicating that drug surveillance and counseling in these groups of patients may be beneficial.

Severe cutaneous adverse drug reactions: Incidence, clinical patterns, causative drugs and modalities of treatment in Assiut University Hospital, Upper Egypt

“…Patients with skin detachment >30% of TBSA, was diagnosed as TEN ( Figure 1), while patients in whom 10% to 30% of TBSA was affected overlap SJS/TEN was diagnosed, and those with skin detachment <10% of TBSA, SJS was diagnosed. 4 Mucous membranes affection was present in all patients. The histopathology findings from the patients who accepted to take skin biopsy were compatible with SJS or TEN.…”

“…2 Bastuji et al 3 areas of denuded skin are major characteristics of SJS and TEN. 4 According to the percentage of total body surface area (TBSA) affected, SJS is characterized by epidermal detachment affecting <10% of TBSA, whereas in TEN >30% of TBSA is affected. In patients with a condition representing an overlap SJS/TEN, 10% to 30% of TBSA is affected.…”

“…In patients with a condition representing an overlap SJS/TEN, 10% to 30% of TBSA is affected. 3,4 Drugs are commonly implicated in the causation of SJS but infection and herpes simplex may also be implicated. 5 In TEN, drugs are the most common cause.…”

“…Bastuji et al 3 classified the bullous SCARs into Stevens‐Johnson syndrome (SJS), overlap SJS/TEN, and TEN. Mucocutaneous tenderness, erythema, hemorrhagic erosions, and necrotic epidermal detachment presenting as blisters and areas of denuded skin are major characteristics of SJS and TEN 4 . According to the percentage of total body surface area (TBSA) affected, SJS is characterized by epidermal detachment affecting <10% of TBSA, whereas in TEN >30% of TBSA is affected.…”

“…According to the percentage of total body surface area (TBSA) affected, SJS is characterized by epidermal detachment affecting <10% of TBSA, whereas in TEN >30% of TBSA is affected. In patients with a condition representing an overlap SJS/TEN, 10% to 30% of TBSA is affected 3,4 . Drugs are commonly implicated in the causation of SJS but infection and herpes simplex may also be implicated 5 .…”