Acute renal failure caused by imiquimod 5% cream in a renal transplant patient: review of the literature on side effects of imiquimod.

Imiquimod is an immunomodulator of the imidazoquinoline group which possesses antiviral and antitumour activities. Although its mechanism of action has not been entirely elucidated yet, imiquimod 5% cream has been shown to be an efficient, long-lasting and safe therapy for multiple actinic keratoses in non-immunosuppressed patients and in transplant recipients. We report the case of a 44-year-old patient with a third renal transplant who developed an acute tubular necrosis confirmed by renal biopsy after the use of imiquimod 5% cream. The result of a literature search revealed a wide variety of side effects attributable to the use of imiquimod.

Post-marketing safety of antineoplasic monoclonal antibodies: rituximab and trastuzumab.

PURPOSE: The aim of this study was to analyse the suspected adverse reactions associated with rituximab or trastuzumab reported to the Spanish Pharmacovigilance System. METHODS: From this national database, we selected the spontaneous reports registered between 1 January 1999 and 1 June 2006 and analysed both age and gender of the patient, the dose prescribed, the severity of the report, the evolution, the latency and recovery periods of the adverse reaction, the reporting odds ratio (ROR) and the presence of other suspected drugs. RESULTS: From 49 927 records registered in the period of analysis, 69 were associated with rituximab and 23 with trastuzumab. White cell disorders (n = 18), hypotension (n = 7), dyspnoea (n = 6) and pneumonitis (n = 4) were the most common adverse reactions associated with rituximab. The mean latency period of white cell disorders was 20.9 +/- 7.8 days, except in two cases where it was clearly longer (87 +/- 13 days). Hypotension and dyspnoea appeared immediately or a few days after the administration of the drug, and rapidly resolved. Pneumonitis seems to be a delayed adverse reaction, which required on average, 3 months to develop. Cardiac failure was the adverse reaction more frequently associated with trastuzumab (n = 7). In five of the seven cases of cardiac failure reported patients had been taking other suspected medications. CONCLUSION: Our results are consistent with the safety profile of rituximab and trastuzumab observed in large randomised clinical trials.

Safety profile of proton pump inhibitors according to the spontaneous reports of suspected adverse reactions.

OBJECTIVE: [corrected] To evaluate similarities and differences in safety among proton pump inhibitors (PPIs) under the usual conditions of prescription. METHODS: A search of spontaneous reports on adverse reactions associated with these drugs and registered between January 1, 2004 and December 31, 2004 was undertaken in the Spanish Pharmacovigilance System Database. We compared the frequency of reports with the consumption of PPIs, and analyzed the organ and system distribution for each PPI. Of the organ and system groups more commonly affected, diarrhea, myalgia, abnormal vision and hepatitis were selected for further analysis. RESULTS: Nearly 8 times more reports for omeprazole compared to other drugs were found but a similar difference was observed in their consumption. Skin and appendage disorders were more frequently reported for omeprazole and rabeprazole, the urinary, female reproductive and endocrine systems for lansoprazole, musculoskeletal for omeprazole and esomeprazole, vision for pantoprazole, rabeprazole and esomeprazole, gastrointestinal tract for omeprazole and lansoprazole and liver and biliary systems for omeprazole, lansoprazole and pantoprazole. Myalgia appears more often in younger patients than diarrhea, abnormal vision or hepatitis and shows longer periods of latency and recovery. The four adverse reactions analyzed were mainly reversible. CONCLUSION: A direct relationship was found between consumption and the number of reports. Some organ and system groups were affected by more than one PPI and this showed a specific pattern of group toxicity to these pharmacological agents. Some reports involved only lansoprazole and these require further analysis.

Spontaneous reporting of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with antiepileptic drugs.

OBJECTIVE: To assess the association between Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN) and antiepileptics including the most recently authorized drugs. METHODS: In the Spanish Pharmacovigilance database, we searched for spontaneous reports of SJS or TEN associated with antiepileptic drugs and analysed: a) reporting odds ratio (ROR), b) age and gender of the patient, c) evolution, d) latency and recovery periods and e) presence or absence of other suspected drugs. RESULTS: A total of 84 reports of SJS and 80 of TEN related to 9 antiepileptic drugs were studied. Reports were mainly associated with phenytoin (SJS: 28; TEN: 43), lamotrigine (SJS: 37; TEN: 20) and carbamazepine (SJS: 14; TEN: 16). Other antiepileptic drugs involved were: valproate, phenobarbital, oxcarbazepine, levetiracetam, primidone and gabapentin. Patients were of a median age of 40 [1-87] and 57.3% of them were women. Cases related to phenytoin were more common in older men and to lamotrigine in younger women. The latency period of SJS and TEN did not exceed the first month of treatment and, in most of the analysed reports, the outcome was recovery. CONCLUSIONS: Our observations support the association of SJS or TEN with phenytoin, carbamazepine, valproate or phenobarbital and enlighten the role of lamotrigine and others such as oxcarbazepine or levetiracetam.

Relevancia clínica de las notificaciones de reacciones adversas de atención primaria recibidas en el centro de farmacovigilancia de Asturias / Clinical relevance of the adverse reactions reports received from primary health care in the pharmacovigilance center of Asturias

Introducción: Analizar la relevancia clínica de las notificaciones de reacciones adversas y, dentro del programa de notificación espontánea, comparar dicha relevancia en las notificaciones recibidas mediante tarjeta amarilla (TA) y OMI-AP. Material y método: Las notificaciones de sospechas de reacciones adversas recibidas entre los años 1998 y 2007 se clasificaron en: 1) espontáneas de profesionales sanitarios; 2) espontáneas de industrias farmacéuticas; 3) casos publicados, y 4) estudios poscomercialización. Del primer grupo se seleccionaron las procedentes de atención primaria, clasificándolas según el formulario (TA u OMI-AP) y analizando su relevancia clínica. Se consideraron clínicamente relevantes las notificaciones que cumplían alguno de los siguientes criterios: 1) principio activo nuevo implicado (<5 años en el mercado); 2) reacción adversa notificada grave o desconocida. Se estudió la evolución anual de las notificaciones totales y relevantes. Resultados: Se obtuvieron 3.150 notificaciones, de las cuales 1.651 eran espontáneas procedentes de médicos de origen extrahospitalario y mostraban una evolución anual en aumento. Al analizar separadamente los 2 formularios se observó un progresivo incremento de la notificación a través de OMI-AP, que además incluía un aumento, aunque menor, de la notificación de casos relevantes. Simultáneamente disminuyó la notificación por TA, que mantiene su porcentaje de notificaciones relevantes. Conclusión: En Asturias, la aceptación del formulario de OMI-AP ha facilitado la notificación de reacciones adversas. Debemos seguir trabajando en sistemas automatizados de recogida de la información para obtener resultados más eficientes en farmacovigilancia (AU)

Introduction: To analyze the clinical relevance of the adverse reactions reports and to compare this relevance with those sent by yellow card (YC) versus OMI-AP formularies within the Spontaneous Reporting Program. Material and method. Reports of suspected adverse reactions received from 1998 to 2007 were classified into one of the following groups: 1) spontaneous from health professionals, 2) spontaneous from drug companies, 3) published cases, 4) post-marketing studies. In regards to the first group, we selected those sent from primary health care and studied their clinical relevance according to the formulary used (YC or OMI-AP). Reports that fulfilled at least one of the following criteria were considered relevant: 1) new drug involved (<5 years in the market), 2) serious or unknown adverse reaction reported. The annual evolution of the relevant and total reports was studied. Results: Out of the 3150 reports analyzed, 1651 were spontaneous from primary health care physicians and showed an increased annual evolution. The separate analysis of the 2 formularies showed a progressive increase in the total reports through the OMI-AP form that included a lower increase in the relevant reports. Simultaneously, the total number of reports received by YC decreased, although the percentage of relevant reports sent with this formulary was maintained. Conclusion: In Asturias, the acceptance of the OMI-AP form has made reporting of adverse reactions easier. We should continue working with automatized systems to collect information in order to obtain more efficient results in Pharmacovigilance (AU)

Reacciones adversas a medicamentos en la revista Oncología

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