DJ FDA, Serono Warn Of Cardiac Risk From MS Drug's Use >SRA
Dow Jones News Services
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The Food and Drug Administration warned health-care professionals and consumers Tuesday of the risk of heart damage from a drug made by Swiss-based Serono SA (SRA) used to treat multiple sclerosis.
The FDA added a boxed warning to the drug, Novantrone, which discusses the cardiac risks. The FDA posted the new label and a letter from Serono to health-care professionals and consumers to its Web site Tuesday.
In its letter, Serono said congestive heart failure can occur in patients taking Novantrone during therapy or for "months to years after termination of therapy." The company said patients need to be tested for heart problems before each dose of Novantrone. The drug is administered about four times a year. Patients with MS shouldn't receive more than 8 to 12 injections of the drug.
The company said it has received reports of heart damage caused by Novantrone occurring early on in treatment. The company didn't immediately return a call for comment.
Novantrone was approved by the FDA to treat chronic MS, or relapsing MS, in 2000. The drug is a chemotherapy agent and is also used to treat cancer. Most chemotherapy agents have a risk of heart damage. MS is a progressive disease that affects the spinal cord and brain and involves damage to nerves that control muscles and vision.
The label also updated information about an increased risk of developing treatment-related leukemia, a blood cancer. According to a study of breast-cancer patients being treated with Novantrone, they had a 1.6% increased risk of developing acute myelogenous leukemia at 10 years. Serono said health-care professionals need to strictly adhere to existing white-blood-cell count monitoring recommendations to patients being treated with Novantrone.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; firstname.lastname@example.org
(END) Dow Jones Newswires