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.

Thalomid is approved in Canada as part of a treatment for multiple myeloma

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 for the blood cancer called multiple myeloma, in combination with melphalan and prednisone.

Capsules of the drug thalidomide at the Celgene Corp. in N.J. The drug is only available in Canada under a controlled distribution program. (Mike Derer/Associated Press)

On Wednesday, Health Canada and the drug's manufacturer Celgene Inc., said the drug's label will be updated to include 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 warned Thalomid users may be at risk of developing blood clots in their arteries.

Thalomid is only available to prescribers and pharmacists who are registered with a controlled distribution program called RevAid.