New Treatment Sanctioned for Bone Marrow Disorder
But similar drug known to cause birth defects
THURSDAY, Dec. 29, 2005 (HealthDay News) -- The Celgene Corp. drug Revlimid (lenalidomide) has been approved by the U.S. Food and Drug Administration to treat a certain form of Myelodysplastic Syndrome (MDS), a bone marrow abnormality.
MDS is a collection of disorders in which the bone marrow doesn't function properly and the body doesn't make enough normal blood cells. Patients often need blood and platelet transfusions and antibiotics to treat infections, the FDA said.
In clinical trials, most MDS patients with deletion 5q cytogenic abnormality didn't require as many transfusions three months after starting treatment with the drug, the agency said.
Some 7,000 to 12,000 cases of MDS are diagnosed each year in the United States. People over age 60 are most susceptible to the disease, whose symptoms include weakness, fatigue, infections, easy bruising, bleeding and fever.
Revlimid is similar to thalidomide, a drug proven to cause severe birth defects. Celgene is still conducting studies to determine if pregnant Revlimid users are subject to similar risks, the agency said. Until the results are known, the FDA said, the company is marketing the drug under a program designed to prevent fetal exposure.
Visit Medline Plus to learn more about MDS.