Safety Alerts & Recalls

What does this mean?

Since PML is very rare, and since CellCept and Myfortic are normally used to treat serious illnesses, it is likely that most patients with a healthy immune system should find the benefit of treatment outweighs the risks.

That said, until further information is available, you should (a) be aware of the possibility of PML, (b) regularly balance the benefits and risks of treatment with your doctor, and (c) tell your doctor if you notice problems such as weakness in the hands or legs, difficulty thinking or concentrating, or a loss of coordination - which could be early signs of the condition.

Potential increased risk of PML

The FDA today informed healthcare professionals that it is investigating a potential link between the use of CellCept and Myfortic and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. The FDA is currently reviewing data from the manufacturers of these products, and anticipates it may take about 2 months to complete this review and/or make appropriate recommendations.

For more information, please visit: more information here

Source: FDA
Publication Date: 2008-04-10
Last Updated: 2009-12-06

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