Saint-Laurent, QC (February, 2005) - Abbott Laboratories, Limited, in cooperation with Health Canada, has informed healthcare professionals of important new safety information concerning HUMIRA (adalimumab).

HUMIRA belongs to a class of products called tumor necrosis factor-blockers or TNF-blockers, and is used to treat people with moderate to severe rheumatoid arthritis (RA). Please note the following safety information:

• Serious disorders of the blood have been reported in patients taking HUMIRA, including a reduction in white blood cells, red blood cells and/or platelets (cells involved in blood clotting). It is unclear whether such blood disorders are directly related to the use of HUMIRA.
  
  
• Patients are advised not to take HUMIRA in combination with another RA drug called anakinra because of the risk of serious infections.

Signs and symptoms of the above blood disorders can vary depending on their severity, but can include any of the following:

• unusual fatigue;
• the abrupt onset of fever and unexplained infection;
• the appearance of small red spots on the skin (petechiae) and unusual bleeding episodes such as unexplained nose bleeds and gingival bleeding.

Patients who experience these or any other unusual symptoms should contact their physician. The prescribing information for HUMIRA will be revised to include the updated safety information.

This advisory letter and a more detailed letter issued to health care professionals on the same subject is posted on Health Canada’s website at http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/index_e.html

Since 1998, clinical trials have been ongoing in Canada with HUMIRA and over 1,700 Canadian patients have participated in these studies. HUMIRA was approved for use in Canada on September 24, 2004. Since its approval, there have been no reports of blood disorders in patients taking HUMIRA. In addition, there have been no Canadian reports of adverse reactions involving the use of both HUMIRA and anakinra.

For media inquiries, please contact Ms. Joan Lister, HealthComm Inc., at (905) 206-1025.

Abbott is committed to ensuring that HUMIRA is used safely and effectively and to providing patients with the most current product information for HUMIRA. Any suspected adverse reactions can be reported to Abbott Laboratories, Limited or the Marketed Health Products Directorate at the following addresses:

original signed by

Mauricio Ede, MD, PhD
Medical Director
Abbott Laboratories, Limited