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La Hepatotoxicidad Del Droxicam

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La Hepatotoxicidad Del Droxicam Vol. 6, n.º 3 julio - septiembre 1993 butlletí groc Institut Català de Farmacologia Universitat Autònoma de Barcelona La hepatotoxicidad del droxicam Los antiinflamatorios no esteroides (AINE) pue- vía oral a animales de experimentación. 15 Cuando den producir alteraciones hepáticas, que van se disuelve en agua y en medio ácido, así co m o desde aumentos leves, transitorios y subclínicos en el quimo gástrico, se hidroliza inmediatamente de los enzimas hepáticos hasta cuadros bien es- a piroxicam y, según el laboratorio fabricante, se tablecidos de hepatitis citolítica, colostásica o absorbe en forma de piroxicam.16 De hecho, la mixta e, incluso, cuadros de hepatitis crónica. administración de droxicam a animales de labora- to r i o 16 y a seres humanos17 no da lugar a concen- No se conoce exactamente la frecuencia de es- traciones pIasmáticas detectables de droxicam,16 tas reacciones de hepatotoxicidad, pero parece sino de piroxicam. No obstante, se ha podido ser muy baja.1 No obstante, el potencial hepato- comprobar recientemente que tras la administra- tóxico no parece ser el mismo para todos los AINE. En realidad, algunos fueron retirados del ción de droxicam o de piroxicam por vía oral a mercado en los años setenta y ochenta por este ratas, los metabolitos que aparecen en orina no motivo (ibufenac, fenclofenac y benoxaprofeno). son los mismos con ambos fármacos; esto indica- Recientemente en España la Comisión Nacional ría que el metabolismo (probablemente hepático) de Farmacovigilancia recomendó la retirada del no es el mismo y que, por tanto, no se puede mercado del bendazac (Bendalina®), un AINE que, hablar de una equivalencia farmacocinética (y toxi- sin una eficacia clínica bien demostrada, se utili- cológica) absoluta entre los dos fármacos. En zaba para el tratamiento de las cataratas.2-4 voluntarios sanos y jóvenes (edades comprendi- das entre 15 y 39 años) droxicam (en forma de piro- Datos procedentes de series de casos y de siste- xicam) tiene una absorción mucho más lenta que la mas de notificación espontánea sugieren que de piroxicam (t1/ 2 de la absorción de 8 h para el pri- sulindac y fenbufeno, y en menor grado fenilbuta- mero y de 2 h para el segundo). Su vida media zona, diclofenac y piroxicam, serían los mas plasmática es de 53 h, pero con amplia variabilidad 5-13 hepatotóxicos. interindividual (los valores de t1/ 2 en los 10 volunta- rios estudiados fueron de 26 a 69 h17 ). No se han Droxicam: ¿mucho más hecho estudios en personas de edad avanzada, lo hepatotóxico? que resulta sorprendente, porque los AINE son sobre todo utilizados por los ancianos. En conse- A principios de 1992 comunicábamos la sospecha cuencia, desconocemos los parámetros farmacoci- de que el droxicam (Drogelon®, Ferpan®, Ombo- néticos en los pacientes que más lo utilizan. la n ®), un nuevo AINE comercializado a mediados de 1990, podría producir hepatotoxicidad con mayor frecuencia que otros Al N E . 14 Hasta la actua- Ensayos clínicos lidad se han notificado 53 casos de reacciones de Conocemos dos ensayos clínicos con distribu- hepatotoxicidad asociadas a su uso. Veintiseis de ción aleatoria y a doble ciego con droxicam, en los estos casos proceden de Cataluña. que ha sido comparado con piroxicam18 o con indometacina.19 En el primero se incluyó a 31 pa- Droxicam: no exactamente cientes con artrosis de rodilla, tratados durante 4 un profármaco del piroxicam semanas con 20 mg al día de droxicam o de piroxicam. Se registró un aumento moderado de El droxicam es un derivado del piroxicam con acti- transaminasas o de la g-GT en cuatro pacientes vidad antiinflamatoria tras su administración por tratados con droxicam y en uno tratado con 9 piroxicam. Todos los casos fueron asintomáticos y meses siguientes a la suspensión de su adminis- mejoraron tras la suspensión del tratamiento.18 tración, 5 tardaron entre 3 y 4 meses y uno no mostraba recuperación de los valores de labora- En el segundo se incluyó a 39 pacientes con ar- torio un año después de haber dejado el trata- trosis de distintas localizaciones. Se comparó dro- miento. En la mayoría de los pacientes la serolo- xicam (20 mg al día) con indometacina (75 mg al gía vírica fue negativa y la ecografía abdominal día) en pacientes de 41 a 64 años, durante 3 se- normal. Tres de ellos también seguían tratamien- manas. Entre los pacientes tratados con droxi- to con otros fármacos potencialmente hepatotóxi- cam, 3 (15%) presentaron alteraciones de las prue- cos (glibenclamida, fenilbutazona e indometacina). bas hepáticas, dos de ellos sin manifestaciones clí- nicas, pero el otro –que simultáneamente había También se han notificado casos en Italia, donde tomado fenobarbital y fenitoína– presentó aumen- el droxicam se comercializó más tarde que en tos más significativos. También se registraron incre- España.27 La figura 1 muestra el perfil de reaccio- mentos de las transaminasas en 3 pacientes trata- nes adversas de los AINE que son objeto de más dos con indometacina (también en otros dos, aun- notificaciones. Se observa que predominan las que padecieron una mononucleosis y una infección reacciones digestivas para todos ellos, excepto por citomegalovirus y virus de Epstein-Barr), pero para droxicam. De los efectos indeseables de todas fueron muy limitadas.19 droxicam, los de hepatotoxicidad son los más no- tificados; la frecuencia de notificación de estos episodios es superior a la del resto de AINE en Datos de farmacovigilancia general y a la del piroxicam en particular (38,1% en comparación con 2,8% del total de notificacio- Hasta ahora la base de datos del Sistema Espa- nes); sin embargo, no se puede descartar que ñol de Farmacovigilancia incluye 139 notificacio- algunos sesgos de notificación hayan contribuido, nes de reacciones adversas a droxicam, de las parcialmente, a originar estas diferencias. que 53 son de hepatotoxicidad. Además, se han notificado casos en revistas médicas.20-26 En Ca- taluña, hasta ahora, hemos recibido 40 notifica- Droxicam en la Comisión Nacional ciones de reacciones adversas, de las que 26 son de Farmacovigilancia de hepatotoxicidad. A finales del año pasado, la Comisión Nacional de Las 26 notificaciones recibidas en nuestro centro Farmacovigilancia trató por segunda vez este se refieren a 15 mujeres y a 10 hombres, de eda- tema. Los estudios de toxicidad hepática aguda y des comprendidas entre 29 y 82 años subaguda recomendados por esta Comisión al (x±DE=59,4±13,4). Todos los enfermos, excepto laboratorio fabricante resultaron negativos; el la- uno, tomaban 20 mg al día de droxicam, princi- boratorio también informó de la posibilidad de que palmente para el tratamiento de cuadros de se hubiera formado una impureza durante el pro- artrosis. El patrón de hepatotoxicidad predomi- ceso de producción, lo que hizo modificar el cita- nante es colostásico. En la mitad de los casos do proceso a partir de agosto de 1992, así (13 pacientes) los síntomas aparecieron durante como retirar del mercado los lotes correspondien- las primeras dos semanas de tratamiento y en un tes al antiguo proceso de producción. La Comi- 89% (23 pacientes) durante el primer mes. Quin- sión también tuvo conocimiento de la existencia ce pacientes (58%) se recuperaron en los dos de nuevos estudios (referidos anteriormente) se- % 50 40 D P 30 Dr 20 I 10 N 0 GI PIEL SNC GRAL HEM RESP PSIQ HEP Otros Figura 1.- Distribución, según los órganos y sistemas afectados, de las reacciones adversas noti- ficadas atribuidas a diclofenac (D; 641 reacciones), piroxicam (P; 481 reacciones), droxicam (Dr; 160 reacciones) indometacina (I; 406 reacciones) y naproxeno (N; 279 reacciones). 10 nº notificaciones 7 Bibliografía 6 1. Anónimo. Butll Groc 1990;3:1-2. 2. Anónimo. Butll Groc 1991;4:5-6. 5 3. Anónimo. Butll Groc 1992;5:1-2. 4. Anónimo. Butll Groc 1993;6:4. 4 5. Helfgott SM, Sandberg-Cook J, Zakim D, 3 Nestler J. JAMA 1990;264:2660-2. 6. Prescott LF. En: Side-effects of anti-inflam- 2 matory drugs, vol 3, dir por KD Rainsford y GP Velo. Dordrecht: Kluwer, 1992:176-87. 1 7. O’Brien WM. En: Side-effects of anti-inflam- matory drugs, vol 3, dir por KD Rainsford y GP 0 4.90 1.91 2.91 3.91 4.91 1.92 2.92 3.92 4.91 1.93 2.93 Velo. Dordrecht: Kluwer, 1992:211-22. Jick H, Derby LE, García Rodríguez LA, Figura 2.- Distribución de las notificaciones de hepatotoxicidad atribui- 8. da a droxicam, según la fecha de inicio del tratamiento (por trimestres). Jick SS, Dean AD. P h a rm a c o t h e ra py 1992; 12:207-12. gún los cuales los metabolitos que se forman tras 9. Koff RS. En: NSAlDs. A Profile of adverse la administración de droxicam por vía oral a ratas effects, dir por IT Borda y RS Koff. Filadelfia: no son los mismos que los que se forman tras la Hanley & Belfus, 1992:133-45. administración de piroxicam. 10. García Rodríguez LA, Pérez Gutthann S, Walker AM, Lueck L. Br Med J 1 9 9 2 ; Finalmente, la Comisión recomendó al labo- 305:865-8. ratorio que identificara y cuantificara los meta- 11. Früs H, Andreasen PB. J Int Med 1 9 9 2 ; bolitos en orina de droxicam, de piroxicam y de 232:133-8. las presentaciones comercializadas de ambos 12. Rabinovitz M, Van Thiel DH. Am J fármacos, con el fin de evaluar si hay diferencias Gastroenterol 1992;87:1696-704. entre ellos, y que informara, en el prospecto de 13. Tarazi EM, Harter JG, Zimmerman HJ, lshak las especialidades que contienen droxicam, de KG, Eaton RA. G a s t r o e n t e r o l o g y 1 9 9 3 ; que se han registrado casos graves de hepato- 104:569-74.
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