Anissa Zaouak1, Fatma Ben Salem2, Sélima Ben Jannet3, Houda Hammami3, Samy Fenniche3. 1. Dermatology Department, Habib Thameur Hospital, 1089 Tunis, Tunisia. Electronic address: anissa_zaouak@yahoo.fr. 2. National Center of Pharmacovigilance, 1002 Tunis, Tunisia. 3. Dermatology Department, Habib Thameur Hospital, 1089 Tunis, Tunisia.
Abstract
BACKGROUND: Bullous fixed drug eruption (BFDE) is a rare and particular adverse drug reaction characterized by localized or generalized blisters and erosions, which can be confused with Stevens-Johnson syndrome, toxic epidermal necrolysis, major erythema multiforme and autoimmune bullous dermatosis. OBJECTIVE: The aim of our study was to assess the epidemiological, clinical and therapeutic features and outcome of BFDE. METHODS: A retrospective and descriptive study collecting all observations of BFDE was conducted in the dermatology department of Habib Thameur Hospital in Tunisia, over an 18-year period (2000-2017). The diagnosis of BFDE was confirmed by histopathological examination and all the patients underwent pharmacovigilance investigation. RESULTS: Totally, 18 cases were enrolled in our study with BFDE. The mean age was 57.9 years with a sex ratio M/F of 1. BFDE was localized in 8 cases and generalized in 10 cases. It was the first episode of BFDE in 11 patients and a recurrence in 7 patients. Drugs involved in the genesis of BFDE in our study were mainly non-steroidal anti-inflammatory drugs in 10 patients and antibiotics in 5 cases. Drug patch tests were performed in four patients on the residual plaques of FDE (fixed drug eruption) and were positive to the suspected drug. A favorable outcome was observed in all our patients under treatment and after suspected drug withdrawal. CONCLUSION: BFDE is a rare adverse drug reaction and could be severe especially when it presents as a generalized eruption. Drugs involved are mainly non-steroidal anti-inflammatory drugs followed by antibiotics.
BACKGROUND: Bullous fixed drug eruption (BFDE) is a rare and particular adverse drug reaction characterized by localized or generalized blisters and erosions, which can be confused with Stevens-Johnson syndrome, toxic epidermal necrolysis, major erythema multiforme and autoimmune bullous dermatosis. OBJECTIVE: The aim of our study was to assess the epidemiological, clinical and therapeutic features and outcome of BFDE. METHODS: A retrospective and descriptive study collecting all observations of BFDE was conducted in the dermatology department of Habib Thameur Hospital in Tunisia, over an 18-year period (2000-2017). The diagnosis of BFDE was confirmed by histopathological examination and all the patients underwent pharmacovigilance investigation. RESULTS: Totally, 18 cases were enrolled in our study with BFDE. The mean age was 57.9 years with a sex ratio M/F of 1. BFDE was localized in 8 cases and generalized in 10 cases. It was the first episode of BFDE in 11 patients and a recurrence in 7 patients. Drugs involved in the genesis of BFDE in our study were mainly non-steroidal anti-inflammatory drugs in 10 patients and antibiotics in 5 cases. Drug patch tests were performed in four patients on the residual plaques of FDE (fixed drug eruption) and were positive to the suspected drug. A favorable outcome was observed in all our patients under treatment and after suspected drug withdrawal. CONCLUSION:BFDE is a rare adverse drug reaction and could be severe especially when it presents as a generalized eruption. Drugs involved are mainly non-steroidal anti-inflammatory drugs followed by antibiotics.