Rituxan Side Effects Linked to Progressive Multifocal Leukoencephalopathy (PML)
On Thursday, the FDA notified oncologists, rheumatologists and other healthcare providers that the rheumatoid arthritis drug Rituxan has been linked to a fatal case of progressive multifocal leukoencephalopathy (PML). An update will be made to the prescription information about the risk of developing the rare brain disease.
Rituxan is a powerful immunosuppressant used for the treatment of rheumatoid arthritis and non-Hodgkin’s lymphoma. The drug is made by Genentech Inc. and Biogen Idec Inc., with annual sales of about $2.3 billion last year.
Warnings were placed on the label in 2006 about potential Rituxan side effects which could cause several viral infections, including progressive multifocal leukoencephalopathy. In 2007, the FDA warned that two people died after using Rituxan for lupas treatment, which is not an approved use.
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Learn MoreProgressive multifocal leukoencephalopathy, commonly referred to as PML, is caused by a polyomavirus called the JC virus. It is a progressive inflammation of the central nervous system and the brain, which could cause symptoms such as confusion, blurred vision, speech difficulties, movement problems, dizziness and loss of balance.
Although PML is rare, the brain infection can worsen over time and there is no known cure. In many cases it ultimately leads to death.
Genentech and Biogen have sent a letter to physicians notifying them about the label changes that will be made about the potential side effects of Rituxan. An update will be made to the prescribing information about a woman treated for arthritis with the drug who developed PML about 18 months after the therapy was stopped. She ultimately died from the brain disease.
This is the third alert issued by the FDA this year involving a drug linked to progressive multifocal leukoencephalopathy. The other drugs include Biogen Idec and Elan Inc.’s multiple sclerosis drug Tysabri, and the organ transplant drugs CellCept and Myfortic.
Tysabri was recalled in 2005 after a number of patients developed PML. It was subsequently reintroduced in 2006 with restrictions on how it can be prescribed.
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KenAugust 7, 2018 at 10:11 am
My wife has PML from the deadly drug RITUXAN. I BROUGHT HER TO NIH CLINIC IN BETHESDA MARYLAND TO SAVE HER LIFE WITH TCELL THERAPY FROM OUR CHILDREN. SHE SURVIVED BUT HAS SEVERE BRAIN DAMAGE. SHE HAS SPOKEN TO ME IN 2 YEARS SINCE RECEIVING RITUXAN. BIOGEN AND GENNETECH MADE 2.3 BILLION DOLLARS ON RITUXAN. THE FDA HAS DONE NOTHING BECAUSE THEY MADE GREAT TAX MONEY. NICE COUNTRY HUH.
NanetteOctober 10, 2012 at 7:37 pm
My husband was administered one dose of rituximab, within 3 days developed 12" of dead bowel, had surgery for that, then died. DOCTORS THAT PRESCRIBE RITUXIMAB AND THE COMPANY THAT PROMOTES IT SHOULD HAVE TO TRY IT OUT FIRST. It was a horrible death and all because of medicines. 1/5 of the doctors thought he had Wegener's and that's why they gave him rituximab. The other 4/5 of the doctors he [Show More]My husband was administered one dose of rituximab, within 3 days developed 12" of dead bowel, had surgery for that, then died. DOCTORS THAT PRESCRIBE RITUXIMAB AND THE COMPANY THAT PROMOTES IT SHOULD HAVE TO TRY IT OUT FIRST. It was a horrible death and all because of medicines. 1/5 of the doctors thought he had Wegener's and that's why they gave him rituximab. The other 4/5 of the doctors he saw did not have a clue.