Thalidomide drug label to warn of cancer risk

A thalidomide drug that is approved as part of treatment for multiple myeloma may increase the risk of other cancers, Health Canada says.

In Canada, Thalomid is approved for use in people aged 65 and older as a treatment forthe blood cancer called multiple myeloma, in combination with melphalan and prednisone.

On Wednesday, Health Canada and the drug's manufacturerCelgene Inc., said the drug's labelwill be updated toinclude this safety information:

• Second primary malignancies, in particular acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), have been observed in an ongoing clinical trial in patients with previously untreated multiple myeloma receiving the combination melphalan, prednisone and Thalomid. The cancers were rarely reported in the "post-market setting."
• The risk of AML and MDS must be taken into account before starting the treatment.

Health Canada said doctors should carefully evaluate patients before and during treatment using standard cancer screening for second primary malignancies.

Earlier this month, the department warnedThalomid usersmay be at risk of developing blood clots in their arteries.

Thalomid is only available to prescribers and pharmacistswho areregistered with a controlled distribution program called RevAid.