Myrl Jeffcoat myrlj@jps.net

FDA warns about Novantrone, considered a last-resort treatment

Updated: 12:38 p.m. ET May 25, 2005

ZURICH - The U.S. Food and Drug Administration warned patients of the risk of heart damage from Serono’s multiple sclerosis drug Novantrone, a niche product.

"Reports received through post-marketing surveillance have shown that diminished cardiac function may occur early on in the treatment with Novantrone," Serono said in a statement posted on the FDA’s Web site.

It added that it had updated the product labeling for the drug.

Novantrone is a last-resort treatment.

"The drug is burdensome already because it has a large side effect catalogue," said Lombard Odier Darier Hentsch analyst Karl-Heinz Koch.

"It is only used in very severe cases anyway. I don’t believe it will have a big effect on Serono or a large impact on the use of the drug," said Lombard Odier Darier Hentsch analyst Karl-Heinz Koch.

Novantrone is one of Serono’s multiple sclerosis products, which the firm sells besides its flagship Rebif multiple sclerosis drug.

The FDA said congestive heart failure, a potentially fatal condition, could occur either during treatment with Novantrone, or months to years after termination of therapy.

The updated label also included information about an increased risk of developing treatment-related leukemia.

"In 1,774 patients with breast cancer who received Novantrone concomitantly with other cytotoxic agents and radiotherapy, the cumulative risk of developing treatment-related AML (acute myelogenous leukemia), was estimated as 1.1 percent and 1.6 percent at five and 10 years, respectively," Serono said in the statement on the Web site.