Un tercer paciente Rituxan ha desarrollado un trastorno cerebral rara y potencialmente mortal, dijo los reguladores de EE.UU.
Los 73 años de paciente de edad, diagnosticado hace tres años con artritis reumatoide, fue tratado con Rituxan en febrero de 2009, según una carta a los médicos de Biogen y la unidad de Roche Genentech.
Ella desarrolló síntomas de cuatro a seis meses más tarde y fue diagnosticado con la infección cerebral llamada leucoencefalopatía multifocal progresiva, o leucoencefalopatía multifocal progresiva, de acuerdo con un comunicado de la Food and Drug Administration de EE.UU..
La enfermedad cerebral se ha relacionado con el medicamento para la esclerosis múltiple Tysabri comercializados por Cambridge, Massachusetts, Biogen y farmacéutica irlandesa Elan Corp.
La Agencia Europea de Medicamentos informó hoy en su página web que el número de casos de LMP en los usuarios de Tysabri ha saltado al 23 de 13 a conocer antes.
Dos casos mortales de la LMP, se han notificado en pacientes con artritis reumatoide usando Rituxan, que principalmente trata los cánceres de la sangre. La mujer fue la primera paciente con artritis reumatoide teniendo Rituxan de haber contraído la enfermedad cerebral que no han sido previamente tratados con un tipo de medicamento antiinflamatorio llamado antagonista del TNF. De Basilea, con sede en Suiza, Roche y co Biogen mercado Rituxan en los EE.UU.
"La incidencia global de comunicación de la LMP en pacientes con artritis reumatoide que recibieron Rituxan es rara (3 informes en aproximadamente 100.000 pacientes con artritis reumatoide que han sido expuestos)," dijeron las compañías en la carta a los médicos.
"Sin embargo, la información hasta la fecha sugiere que los pacientes con AR que reciben Rituxan tienen un mayor riesgo de LMP."
Rituxan developed a rare and potentially fatal brain disorder, U.S. regulators said.
The 73-year-old patient, diagnosed three years ago with rheumatoid arthritis, was treated with Rituxan in February 2009, according to a letter to physicians from Biogen and Roche’s Genentech unit. She developed symptoms four to six months later and was diagnosed with the brain infection known as PML, or progressive multifocal leukoencephalopathy, according to a statement from the U.S. Food and Drug Administration.
The brain disease has been linked to the multiple sclerosis drug Tysabri marketed by Cambridge, Massachusetts-based Biogen and Irish drugmaker Elan Corp. The European Medicines Agency reported today on its Web site that the number of PML cases in Tysabri users has jumped to 23 from 13 disclosed earlier. Two fatal cases of PML have been reported in rheumatoid arthritis patients using Rituxan, which primarily treats blood cancers.
The woman was the first rheumatoid arthritis patient taking Rituxan to have contracted the brain illness who was not previously treated with a type of anti-inflammatory drug called a TNF antagonist. Basel, Switzerland-based Roche and Biogen co- market Rituxan in the U.S.
“The overall reporting incidence of PML in patients with rheumatoid arthritis receiving Rituxan is rare (3 reports in approximately 100,000 rheumatoid arthritis patients that have been exposed),” the companies said in the letter to doctors. “However, the information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.”
The 73-year-old patient, diagnosed three years ago with rheumatoid arthritis, was treated with Rituxan in February 2009, according to a letter to physicians from Biogen and Roche’s Genentech unit. She developed symptoms four to six months later and was diagnosed with the brain infection known as PML, or progressive multifocal leukoencephalopathy, according to a statement from the U.S. Food and Drug Administration.
The brain disease has been linked to the multiple sclerosis drug Tysabri marketed by Cambridge, Massachusetts-based Biogen and Irish drugmaker Elan Corp. The European Medicines Agency reported today on its Web site that the number of PML cases in Tysabri users has jumped to 23 from 13 disclosed earlier. Two fatal cases of PML have been reported in rheumatoid arthritis patients using Rituxan, which primarily treats blood cancers.
The woman was the first rheumatoid arthritis patient taking Rituxan to have contracted the brain illness who was not previously treated with a type of anti-inflammatory drug called a TNF antagonist. Basel, Switzerland-based Roche and Biogen co- market Rituxan in the U.S.
“The overall reporting incidence of PML in patients with rheumatoid arthritis receiving Rituxan is rare (3 reports in approximately 100,000 rheumatoid arthritis patients that have been exposed),” the companies said in the letter to doctors. “However, the information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.”
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