Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE).—US Food and Drug Administration.
MMF is approved and widely used for prevention of organ rejection in kidney, heart, or liver transplant recipients and is also used off-label with corticosteroid for treating lupus nephritis. At the 8th International Congress on SLE held in Shanghai last May, Tak Mao Chan, MD, professor of medicine at the University of Hong Kong's Queen Mary Hospital in China, said, "The favorable efficacy and tolerability profile, and the ease of treatment without hospitalization or intravenous drug administration has resulted in [MMF’s and corticosteroid’s] being increasingly adopted as standard therapy, often before regulatory approval."According to the FDA statement, “Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE).... This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action.”
PML is a rare demyelinating disorder that affects the central nervous system due to reactivation of polyomavirus (also known as JCV, after the patient in whom it was first discovered). The virus is nearly ubiquitous but remains latent in most people in the absence of immune suppression.
PML symptoms include weakness or paralysis, vision loss, impaired speech, and cognitive deterioration. PML is similar to multiple sclerosis but destroys myelin-producing oligodendrocytes rather than just the myelin itself, and produces intranuclear inclusions. PML progresses more quickly?patients typically die within 4 months of onset.
On November 8, 2007, Roche submitted to the FDA an evaluation of its PML cases in patients who took CellCept in addition to other immunosuppressive medicines, along with recommendations for including information about PML in the drug’s prescribing information. The FDA is reviewing the submitted data, including postmarketing reports it has received of PML in patients who took CellCept or the related drug mycophenolate acid (Myfortic®, Novartis Pharmaceuticals AG). The agency expects to complete review of the postmarketing reports and proposed new labeling in about 2 months.
The agency said, “Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurological signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. Decreasing total immunosuppression may improve the outcome of patients who develop PML.”
Reference
1. Communication about an ongoing safety review of CellCept (mycophenolate mofetil) and Myfortic (mycophenolate acid) [press release]. US Food and Drug Administration; April 10, 2008. http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate.
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