[Assessment off-label prescribing in Dermatology]. / Evaluation des prescriptions hors AMM en Dermatologie.

INTRODUCTION: The official policy of the French National Health Insurance system is to deny reimbursement for drugs prescribed for off-label indications. The objectives of this study were 1) to quantify the use of off-label prescriptions by physicians from a hospital department of dermatology in France; 2) to characterize these off-label prescriptions; 3) to assess data from the literature on the appropriateness of these off-label prescriptions. PATIENTS AND METHODS: For each patient consulting between February 1 and April 1, 2001, the symptom or the disease that was treated and the type of prescription were recorded on standard forms. RESULTS: Eighty six percent of prescriptions were labelled, 14 p. 100 were off-labelled. Inflammatory and hypersensitivity dermatoses were the most frequent indications of off-label prescriptions (26 p. 100). Treatments which most frequently corresponded to off-label prescriptions were topical corticosteroids and methotrexate. Examination of the literature showed that 70 p. 100 of the off-label prescriptions were not based on strong data from evidence-based-medicine. Many off-label prescriptions were made by the most graduate physicians. DISCUSSION: This study showed a great number of off-label prescriptions in dermatology. These prescriptions were often related to rare diseases that were managed by senior dermatologists. These off-label prescriptions were rarely in accordance with data from evidence-based-medicine.

[Bullous pemphigoid induced by spironolactone]. / Pemphigoïde régressive après arrêt d'un diurétique contenant de l'aldactone.

INTRODUCTION: The role of spironolactone as pemphigoid-inducing agent has recently been suggested. We report a new case of pemphigoid probably induced by spironolactone. The disease resolved after withdrawal of the diuretic drug containing aldactone. OBSERVATION: A 76 year-old patient was hospitalized for eczematiform lesions and severe pruritus. Histological and immunological investigations led to the diagnosis of pemphigoid. For several years, the patient had been treated with acarbose, amlodipine, fluvastatine, buflomedil, lysine acetylsalicylate and a spironolactone-furosemide association. On withdrawal of spironolactone alone, the cutaneous lesions regressed spontaneously within 15 days and no relapse was noted 30 months later. DISCUSSION: Numerous observations have suggested the role of certain drugs in the occurrence of pemphigoid. A recent test case study concerning drugs administered to patients suffering from pemphigoid has shown the significant association with spironolactone and neuroleptics. In our case report, the imputability of spironolactone is plausible. Because of the poor prognosis of pemphigoid, essentially due to iatrogenic complications, it is valuable to be able to delay the initiation of specific treatment for a few days, in patients receiving spironolactone.