[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.

[Safety of SGLT2 inhibitors. A review of the adverse drug reactions registered in a national database]. / Seguridad de los iSGLT-2. Revisión de las reacciones adversas notificadas a nivel nacional.

OBJECTIVE: To analyse the adverse drug reactions (ADRs) caused by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) notified in Spain since they have been on the market. MATERIAL AND METHODS: An analysis was made of all the notifications registered in the Spanish Pharmacovigilance System of drugs for human use, arising from the use of SGLT2i. RESULTS: A total of 311 notifications were recorded, of which 169 (54.34%) were related to dapagliflozin, 81 (26.05%) to empagliflozin, and 61 (19.61%) to canagliflozin. There was a ratio of 52.1% women to 47.9% men. The mean age was 62.07±12.17years. There were 167 (53.7%) notifications were classified as non-serious and 144 (46.3%) as serious. A total of 534 ADRs were notified, with the most common being urinary tract infections in 37 (6.9%) cases, diabetic ketoacidosis in 30 (5.6%), balanoposthitis in 24 (4.5%), ketoacidosis in 16 (3%), vulvovaginal candidiasis in 16 (3%), dizzy spells in 11 (2.1%), and 10 (1.9%) with dysuria, Candida balanitis, and vulvovaginal pruritus. As regards the outcomes of the 534 ADRs, 55.6% recovered with no sequelae, with 14% still recovering, 4.9% not recovered, fatal in 1.1%, and unknown in 24.3%. CONCLUSIONS: The majority of the ADRs notified are infections of the urogenital tract, ketoacidosis, and kidney damage. Although the majority of the former were not serious, the ketoacidosis and kidney damage were, leading to hospital admission and being life threatening in some patients. For these reasons, it is recommended that they are, prescribed with caution, the warnings published by the health authorities consulted, as well as notify any ADR that is suspected in this therapeutic group, in order to improve and provide us with further knowledge.

[Pulmonary thromboembolism in primary care]. / Tromboembolismo pulmonar en atención primaria.

The Primary Care physician must know the risk factors and to suspect the presence of a pulmonary thromboembolism (PTE) when there is a compatible clinical picture. We present two cases of a massive PTE in young healthy women in whom the taking of ethinylestradiol combined with cyproterone acetate was the only existing risk factor. We believe that the recommendations of the Spanish Medicines Agency should be followed and prescribe those contraceptives that have less than 30ug of ethinylestradiol and a second generation gestagen.

[Ischaemic stroke in a patient with giant aneurysms in the internal carotid]. / Ictus isquémico en un paciente conaneurismas gigantes de carótida interna.

INTRODUCTION: Presentation of signs and symptoms of haemorrhage and/or ischaemia associated to an intracranial dissecting aneurysm is quite frequent. CASE REPORT: A 77-year-old male with a history of a stroke probably due to a cardioembolic causation, and consequently anticoagulation therapy was established. Ten years later, a tomography scan performed because of persistent headaches revealed the presence of fusiform mirror aneurysms in both supraclinoid carotids and early stages of development in the two middle cerebral arteries with predominance of the left-hand side. The anticoagulation therapy was withdrawn. Said aneurysmal alterations did not exist in the previous study, and so they are thought to have originated due to spontaneous dissection. A month later the patient suffered a stroke in the territory of the right middle cerebral artery, caused by partial occlusion of the aneurysm by a thrombus that gave rise to turbulent flow; distal micro-embolisms were also detected in the right middle cerebral artery. Our aetiological hypothesis, in view of the way events progressed, is an arterio-arterial embolism from the aneurysmal thrombus. Supported by data from the specialised literature available on the matter, we decided to implement surgical treatment, although this possibility was rejected by the family; the decision was thus taken to establish an antiaggregating treatment regimen and follow-up. CONCLUSIONS: Giant aneurysms are a potential source of haemorrhagic events, but we must not forget that secondary ischaemic events may also appear; more especially, the aneurysmal lumen can become partially occluded by thrombi and these then become the focus point for embolic events. A complete neuro-ultrasonographic study would be a very appropriate option with which to tailor the therapeutic decision to each patient.