Canada. Abbott Laboratories Limited has issued a 'Dear Health-care Professional' letter to advise of the addition of new safety information to the adalimumab (Humira, a monoclonal antibody directed against tumor necrosis factor-a) prescribing information, endorsed by Health Canada.

The new safety information will also be included in the revised Canadian Product Monograph. Abbott highlights that there have been reports of serious blood dyscrasias, including leukopenia, pancytopenia and thrombocytopenia, in patients receiving adalimumab (Humira). It is not clear whether there is a causal relationship with adalimumab, and none of the reports was received in Canada. Abbott also recommends against the use of adalimumab (Humira) in combination with anakinra (an interleukin-1 antagonist), as there is a risk of severe infections. This advice stems from the observation of serious infections in patients who received anakinra concurrently with another tumour necrosis factor antagonist in clinical studies.

Reference:

'Dear Health-care Professional' letter from Abbott Laboratories Limited, 2 February 2005. Available on the internet at www.hc-sc.gc.ca