FDA warning on Cellcept and Anemia

The Wall Street Journal has reported that the U.S. Food and Drug Administration (FDA) is is warning doctors that organ transplant drug Cellcept, may cause a type of severe anemia. Recently, the FDA has asked Roche, the maker of Cellcept, to make stricter warning labels regarding the risks involved in using Cellcept.

The U.S. Food and Drug Administration on Friday warned doctors about a certain type of anemia in patients being treated with the Roche (ROG.VX) kidney-transplant drug Cellcept.

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Last month, the FDA said it was requiring Roche and other manufacturers of certain drugs used to prevent the rejection of transplanted kidneys to warn of certain serious infections.

The drugs, including Cellcept, Myfortic by Novartis AG (NVS) and Wyeth's (WYE) Rapamune, already carry the agency's toughest boxed warning discussing their various risks.

The FDA said the drug labels must discuss an increased risk of "opportunistic infections," including activation of latent viral infections such as one caused by the BK virus.

The anemia the FDA is speaking of is PRCA or Pure Red Cell Aplasia. It is a severe form of anemia wherein the bone marrow ceases produce red blood cells because PRCA affects the production process of red blood cells within the bone marrow.

Like many other transplant medications, Cellcept carries a number of risks and produces a number of side effects. It is a very good drug in warding off rejection and is being used by close to 90% of transplant centers in the U.S.

As in many instances, with kidney transplants or organ transplants as a whole, the need for weighing the good against the bad and hopefully coming up with a harmonious balance is the key.

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