FDA issues heart risk warning for Serono multiple sclerosis drug
The FDA warned patients yesterday that Serono's multiple sclerosis (MS) drug Novantrone poses certain heart risks.
"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. The company said it has updated product labeling for the drug.
According to the FDA, congestive heart failure could occur either during treatment with Novantrone or months to years after termination of therapy.
Novantrone had sales of $83.9 million in 2004, company figures showed.
The MS category has been riddled with safety concerns in recent months.
In February, Biogen Idec and Elan announced the voluntary withdrawal of their jointly- marketed MS drug Tysabri after at least two patients died after contracting PML, or progressive multifocal leukoencephalopathy, a rare brain disease. Biogen was dealt another blow in March when the FDA issued a warning concerning its MS drug Avonex, stating the drug could cause severe liver damage in rare cases. That same month, GlaxoSmithKline was ordered by the FDA to halt a trial of its MS drug, which is similar to Tysabri.