FDA: Celltep raises severe anemia risk

Rachel Stockton (rachels@foodconsumer.org)

Friday the FDA announced that it is requiring an additional warning to the drug, Celltep, which is manufactured by Roche (ROG VX). The drug is a transplant drug routinely given to kidney transplant patients.

According to the FDA, Celltep can lead to a severe form of "pure red cell asplasia;" an illness marked by severe anemia. Patients suffering from the illness experience symptoms of extreme fatigue, lethargy and paleness of the skin.

This isn't the first time the drug has garnered the attention of the FDA. As of last month, Roche is required to let physicians and patients know about the risk of serious infection that has been reported after taking the medication. Researchers maintain that the infection risk comes from fact that Cellcept weakens the immune system in an effort to stave off the body's resistance to the transplanted kidney.

The FDA urges patients to inform their physician if they experience any of the following symptoms which may be indicative of the asplaisia: confusion, difficulty with routine decision making, and apathy .

The risk to women who are pregnant is even more serious; the FDA strongly discourages women who are pregnant from using the drug, going so far as to suggest a woman who can potentially become pregnant should take two different types of birth control while taking Cellcept.

The drug can cause a brain infection, progressive multifocal leukoencephalopothy, that can ultimately lead to death.

Neutrophils, or white blood cells, are reduced while taking Cellcept. This can ultimately lead to serious infections, as neutrophils are what the body uses to intercept infections.

Children display their symptoms a bit differently. If a child who has received a donated organ has diarrhea, respiratory problems, blood infection (sepsis) and high blood pressure, the health care provider should be contacted immediately.