Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
CELLCEPT® AND MYFORTIC® LINKED TO RARE BLOOD DISEASE
August 14, 2009. The U.S. Food and Drug Administration announced that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with the anti-rejection drugs CellCept® and Myfortic®. Pure red-cell aplasia (PRCA) is a rare hematologic disease characterized by anemia, reticulocytopenia, and absence of bone marrow erythroid precursors. In some cases, the PRCA was found to be reversible with dose reduction or cessation of CellCept® therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk. Read the FDA label change
CellCept® and Myfortic® are anti-rejection medications used to prevent your body from rejecting a kidney, liver, and/or heart transplant and are usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication. The drugs lower your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a heart, liver or kidney. This is because the immune system treats the new organ as an invader. There are also reports of off-label use of CellCept® in the treatment of lupus nephritis and Crohn's disease.
CellCept® received FDA approval for the prevention of organ rejection in transplanted kidneys in 1995, in hearts in 1998 and in livers in 2000. On May 4, 2009, the FDA approved the first generic versions of Cellcept® (mycophenolate mofetil) 250 mg capsules and 500 mg tablets. CellCept® is distributed in the U.S. by Roche Laboratories, Inc. Generic forms of the drug have been approved to be marketed by the following firms: Roxane Laboratories, Inc., Mylan Pharmaceuticals, Inc., and Sandoz Inc.
Myfortic® (mycophenolic acid) was first approved for use in March, 2004. The drug is in tablet form and used in combination with cyclosporine and corticosteroids to prevent organ rejection. Myfortic® is made by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
If you or someone you love took Myfortic® or CellCept® capsules or tablets or had injections after an organ transplant, or for lupus or Crohn's disease, and suffered adverse effects, you may be entitled to financial compensation. Please fill out our online form, or call 1-850-444-9500 or toll free at 1-888-839-3775 to discuss your valuable legal rights with one of the experienced anti-rejection medicine injury lawyers at our firm.
Evers & Preston, PL
609 West Chase Street
Pensacola, FL 32502-4711
Telephone: 1-850-444-9500 | Toll Free: 1-888-839-3775
