Safety Alerts & Recalls

What does this mean?

The risk of infection with immunosuppressants such as Mycophenolate is a well known risk of this medicine. Today's alert provides new information about the types of infections that have been experienced by kidney transplant patients taking Mycophenolate. Since most patients will find the benefits of taking Mycophenolate will continue to outweigh the risks, this alert is simply a good reminder to watch for signs of infection while taking Mycophenolate. If you develop sore throat, cough, fever, chills, extreme tiredness, flu-like symptoms, warm, red, or painful skin, or other signs of infection, please contact your doctor as soon as possible.

If you have any other questions or concerns about Mycophenolate, please follow up with your doctor.

FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants

The FDA is requiring the makers of certain immunosuppressant drugs to strengthen warnings in the prescribing information. The FDA is requiring the labeling changes based on its review of reported adverse events. The updated prescribing information for these immunosuppressant drugs will warn that immunosuppressed patients are at increased risk for opportunistic infections, including serious viral infections. These infections include BK virus-associated nephropathy, which can mainly affect kidney transplant patients. Such infections may lead to serious outcomes, including kidney graft loss.

These labeling changes are required for the following immunosuppressant drugs: - sirolimus marketed as Rapamune

- cyclosporine marketed as Sandimmune and generic

- cyclosporine modified marketed as Neoral and generic

- mycophenolate mofetil marketed as Cellcept and generic

- mycophenolic acid marketed as Myfortic

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-07-14
Last Updated: 2009-12-05

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