* Patients may have fatigue, unusual paleness of skin
* Some cases are reversible if drug stopped or lowered
WASHINGTON, Aug 14 (Reuters) - A Roche Holding AG ROG.VX transplant drug will carry a new warning about a type of anemia seen in some patients, U.S. regulators said on Friday.
The prescribing information for CellCept will include information about cases of pure red cell aplasia (PRCA), a type of anemia that can cause fatigue, lethargy or abnormal paleness of the skin, the Food and Drug Administration said.
CellCept is used to suppress the immune system to prevent patients’ bodies from rejecting a transplanted organ. It is also available under the generic name mycophenolate mofetil.
Some PRCA cases were reversible when the CellCept dose was lowered or the drug was stopped, Roche said in a letter to doctors. Reduced immunosuppression, however, can put a transplanted organ at risk, and doctors should consider the need to prevent rejection, the company’s letter said.
Forty-one PRCA cases were reported to Roche from 1995, when the drug was approved in the United States, through February 2008, Roche spokesman Chris Vancheri said.
The FDA notice was posted here
Reporting by Lisa Richwine. Editing by Robert MacMillan