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Celgene Updates Warning Labels on Thalomid

Filed May 23rd, 2013 Laurie

Celgene Inc. has notified its customers and people taking its drug Thalomid (thalidomide) of revised warnings that include potential side effects of the medication.

Health Canada has endorsed a message from the drug company that informs the public about its revised Thalomid warnings. The new warnings indicate that taking Thalomid may increase a patient’s risk of suffering acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), both of which are considered second primary malignancies. These risks were identified during an ongoing clinical trial of the drug in which it isprescribed to patients suffering from untreated multiple myeloma.

Celgene says there is a statistically significant increased risk of AML or MDS in patients with untreated multiple myeloma receiving melphalan, prednisone, and thalidomide, compared with patients treated with lenalidomide and dexamethasone.

In its communication with physicians and the public, Celgene Inc. urges doctors: “The risk of AML and MDS must be taken into account before initiating treatment with Thalomid in combination with melphalan and prednisone (MPT). Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies.”

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