Análisis de las notificaciones de úlceras cutáneas inducidas por medicamentos en España / Analysis of notifications of drug-induced skin ulcers in Spain

Las úlceras cutáneas son un serio problema de salud, el cual tiene repercusiones socioeconómicas y laborales muy importantes con una elevada tendencia a la cronicidad y recidiva, estimándose que hasta el 50% de ellas permanecerán activas entre 6 meses y un año. Objetivo: Estudio del papel de los medicamentos en la etiología de las úlceras cutáneas. Material y método: Estudio de todas las notificaciones espontáneas relativas a úlceras cutáneas que constan en la base de datos del Sistema Español de Farmacovigilancia de medicamentos de uso humano.Resultados: Se identificaron 292 notificaciones en las que constaban sospechas de reacción adversa a medicamentos (RAM) del tipo lesión ulcerosa relacionadas con el consumo de medicamentos. Estaban implicados 369 medicamentos que suponen 427 principios activos. Las úlceras fundamentalmente aparecían en mujeres con una media de edad de 56,6 años. Los medicamentos sospechosos más frecuentemente notificados fueron los iSGLT-2, vacunas frente al COVID-19, metotrexato, hidroxicarbamida, trimetropim-sulfametoxazol, foscarnet trisódico hexahidrato, ribavirina, docetaxel, acenocumarol e imiquimod y asociación de lidocaína Hcl-pentosano polisulfato sodio-triamcinolona acetónido. Discusión: Numerosos medicamentos tienen como reacción adversa la aparición de úlceras. No debería descartarse esta posibilidad ante la aparición de una lesión cutánea nueva tras la administración de un nuevo medicamento dado que el 25% de las RAM eran desconocidas en el momento de su notificación, como eran los casos de úlceras asociadas a los i-SGLT2 y a las vacunas contra el COVID al inicio de su comercialización; sin embargo, gracias al hecho de seguir notificando las sospechas de RAM, se crearon alertas sanitarias advirtiendo de este hecho y es por ello que aconsejamos seguir notificando cualquier sospecha de RAM a los sistemas regionales de farmacovigilancia.(AU)

Skin ulcers are a serious health problem with significant socioeconomic and labour repercussions and a high tendency to chronicity and recurrence; approximately, up to 50% remain active between six months to one year. Aim: To study the role of drugs in the aetiology of skin ulcers. Material and method: A comprehensive study of all spontaneous reports related to skin ulcers that appear in the Spanish Pharmacovigilance System of Medicines for Human Use database. Results: A total of 292 reports were identified containing suspected adverse drug reactions (ADRs) of ulcer lesion type. Three hundred sixty-nine medications with 427 active ingredients were identified. The ulcers appeared mainly in women with a mean age of 56.6 years. The most frequently reported suspected drugs were SGLT-2, vaccines against COVID-19, methotrexate, hydroxycarbamide, trimethoprim-sulfamethoxazole, foscarnet trisodium hexahydrate, ribavirin, docetaxel, acenocumarol and imiquimod, and the combination of lidocaine Hcl-pentosan polysulfate sodium-triamcinolone acetonide. Discussion: Numerous medications may cause ulcers as an adverse reaction. This possibility should not be ruled out when a new skin lesion appears after the administration of new drugs since 25% of the ADRs were unknown at the time of their notification, as were the cases of ulcers associated with i-SGLT2 and vaccines against COVID at the beginning of their commercialization. However, informative health alerts can be generated by continuously notifying suspected ADRs, so we strongly advise reporting any suspected ADRs to the regional pharmacovigilance system.(AU)

[Analysis of notifications of drug-induced skin ulcers in Spain]. / Análisis de las notificaciones de úlceras cutáneas inducidas por medicamentos en España.

Skin ulcers are a serious health problem with significant socioeconomic and labour repercussions and a high tendency to chronicity and recurrence; approximately, up to 50% remain active between six months to one year. AIM: To study the role of drugs in the aetiology of skin ulcers. MATERIAL AND METHOD: A comprehensive study of all spontaneous reports related to skin ulcers that appear in the Spanish Pharmacovigilance System of Medicines for Human Use database. RESULTS: A total of 292 reports were identified containing suspected adverse drug reactions (ADRs) of ulcer lesion type. Three hundred sixty-nine medications with 427 active ingredients were identified. The ulcers appeared mainly in women with a mean age of 56.6 years. The most frequently reported suspected drugs were SGLT-2, vaccines against COVID-19, methotrexate, hydroxycarbamide, trimethoprim-sulfamethoxazole, foscarnet trisodium hexahydrate, ribavirin, docetaxel, acenocumarol and imiquimod, and the combination of lidocaine Hcl-pentosan polysulfate sodium-triamcinolone acetonide. DISCUSSION: Numerous medications may cause ulcers as an adverse reaction. This possibility should not be ruled out when a new skin lesion appears after the administration of new drugs since 25% of the ADRs were unknown at the time of their notification, as were the cases of ulcers associated with i-SGLT2 and vaccines against COVID at the beginning of their commercialization. However, informative health alerts can be generated by continuously notifying suspected ADRs, so we strongly advise reporting any suspected ADRs to the regional pharmacovigilance system.