The FDA is warning doctors and multiple sclerosis (MS) patients about the risk of heart failure and leukemia from the MS drug Novantrone.
Patients may be more vulnerable if they have a history of heart disease or heart problems. Screening for heart failure should be done prior to starting treatment with Novantrone and prior to all doses administered, says the drug's maker, Serono.
Patients with heart failure should not receive Novantrone, the company says.
A Serono letter to doctors about Novantrone is posted on the FDA's web site. The letter includes a revised warning label, which has what the FDA calls "additional" and "supplemental" information about heart and leukemia risks.
Novantrone is used to reduce neurological disability and/or the frequency of clinical relapses in patients with several types of MS, says Serono. Those conditions are secondary (chronic) progressive MS, progressive-relapsing MS, or worsening relapsing-remitting MS.
Novantrone is not indicated for patients with primary progressive MS, says Serono.
"Diminished cardiac function may occur early on in treatment with Novantrone," says Serono's letter, citing postmarketing reports.
"Congestive heart failure, potentially fatal, may occur either during therapy with Novantrone or months to years after termination of therapy," says the revised label. It also says all patients should be carefully assessed for cardiac signs and symptoms — such as shortness of breath, extreme fatigue with exertion, and leg swelling — prior to the start of Novantrone therapy.
The label says heart risks may be higher in patients taking Novantrone who have current or past heart disease, those who have had (or are getting) radiation therapy to the chest, those who have previously taken cancer-fighting drugs that can affect the heart — such as anthracyclines or anthracenediones — and those who are also taking other drugs that could cause heart damage.
Risk of Treatment-Related Leukemia
The revised label says that there have been reports of acute myelogenous leukemia (AML — a white blood cell cancer) in some MS and cancer patients who have taken Novantrone.
Leukemia risk was 0.25 percent higher in one group of Novantrone-treated MS patients who were followed for varying periods of time, says the label. It also says that in 1,774 breast cancer patients who took Novantrone along with other cancer drugs which might be toxic, and who had radiation therapy, the risk of developing this treatment-related complication (AML) was 1 percent at five years and 1.5 percent at 10 years.
Treatment-related leukemia is more common "when anthracyclines are given in combination with DNA-damaging antineoplastic agents (cancer fighting drugs), when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracylines have been escalated," says the label.
Patients taking Novantrone should strictly follow recommendations to monitor blood cell count, and regular blood cell counts should be monitored after treatment stops, says Serono.
Serono says it will take questions about Novantrone's safety information at (888) 275-7376 and that doctors should report any problems with Novantrone to the FDA.
SOURCES: News release, FDA. Novantrone letter to health care professionals, Serono. Reuters.