FDA Investigates Link Between Transplant Drugs and Progressive Multifocal Leukoencephalopathy

Yael Waknine

Disclosures

April 11, 2008

April 11, 2008 — A safety review is being conducted to determine whether mycophenolate mofetil (CellCept, Hoffman-LaRoche, Inc) and its metabolite, mycophenolic acid (Myfortic, Novartis Pharmaceuticals, Inc), increase the risk for progressive multifocal leukoencephalopathy (PML), the US Food and Drug Administration (FDA) announced yesterday in an early communication.

PML is a rare and frequently fatal demyelinating disease of the central nervous system that primarily affects immunocompromised patients. It is caused by activation resulting from unknown factors of a polyomavirus, also known as the JC virus, which is latent in 80% of healthy adults.

Signs and symptoms of PML may include vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program.

Roche has provided the FDA with postmarketing reports of the condition in patients receiving mycophenolate mofetil to prevent transplant rejection and for unlabeled uses such as systemic lupus erythematosus. The company also has submitted recommendations to the agency regarding the inclusion of PML information in the product safety labeling, as is the case in the European Union.

Similar information has been requested from Novartis regarding the incidence of PML in patients treated with mycophenolic acid. According to the FDA, the review process is expected to take about 2 months.

In the interim, healthcare professionals are advised to consider PML in the differential diagnosis of immunocompromised patients reporting focal neurologic symptoms on mycophenolate mofetil or mycophenolic acid therapy. Decreasing total immunosuppression may improve the outcome of patients who develop PML, the FDA said.

Mycophenolate mofetil is indicated to prevent rejection of allogenic renal, cardiac, or hepatic transplants. Mycophenolic acid is indicated for the prophylaxis of organ rejection in patients receiving allogenic renal transplant.

Adverse events associated with use of mycophenolate mofetil and mycophenolic acid should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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