Revlimid Legal Information
Revlimid® (lenalidomide) was approved by the FDA to treat patients with multiple myeloma, a bone-marrow cancer in combination with another drug. The product is also approved to treat another bone-marrow condition called myelodysplastic syndromes.
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Revlimid Causing Cancer
In a drug-safety communication posted to the FDA’s website Monday, the agency said data from clinical trials of Revlimid® showed newly diagnosed patients treated with Revlimid® had an increased risk of developing second types of cancer compared to similar patients who received a placebo. The agency said there was an increased risk of developing acute myelogenous leukemia, a type of blood cancer, myelodysplastic syndromes and Hodgkin lymphoma. The drug is also quite expensive, more than $163,000 for a year of treatment, and there was no data indicating whether quality of life improved enough to justify the cost.
Multiple myeloma is a result of the accumulation of plasma cells — a form of white blood cells — in the bone marrow, where they interfere with production of healthy blood cells. It affects between 1 and 4 of every 100,000 people and accounts for about 1% of all U.S. cancers. It is more common in men than in women, and twice as common in blacks as in whites. Average survival is about three to four years, but newer treatments, such as high-dose drug therapy and bone-marrow transplants can extend survival to as long as seven years. One analysis looked at three studies of patients with newly diagnosed multiple myeloma who received initial chemotherapy or chemotherapy and blood-stem-cell transplantation followed by treatment with Revlimid® or a placebo. The FDA said there were 65 second primary malignancies, or cancer, among 824 patients in the Revlimid® treatment arms, compared to 19 second primary malignancies among 665 patients in the treatment arms that didn’t include Revlimid®.
The FDA said the information has been added to the Revlimid® label, which is aimed at giving information about products to doctors, and that patient information is being updated.
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The FDA said doctors “should consider both the potential benefit of Revlimid® and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk.” Patients with concerns should contact their doctors. Patients taking Revlimid® should not discontinue use of the drug without consulting their physician. If you have any questions or concerns regarding the drug Revlimid®, feel free to contact my office at 800-285-HURT or use the link to the right.