Subject: Progressive Multifocal Leukoencephalopathy (PML) reported in patients receiving BENLYSTATM (belimumab) for Systemic Lupus Erythematosus (SLE)
MISSISSAUGA, ON, April 25, 2014 /CNW/ - GlaxoSmithKline Inc, (GSK) in consultation with Health Canada, would like to inform you of important new safety information for patients currently receiving BENLYSTATM (belimumab).
BENLYSTATM is a drug used to treat adult patients with SLE (also known as lupus), who are also receiving other medicines for this condition.
Progressive multifocal leukoencephalopathy (PML) is a serious brain condition caused by the John Cunningham virus (JC virus) in individuals with suppressed immune system. It can cause severe disability or death.
Two cases of PML have now been reported out of approximately 15,000 patients with SLE who have so far been treated with BENLYSTATM. While the exact role of BENLYSTATM in the development of PML is not yet clear, its contribution to this risk cannot be excluded. Based on the information to date, physicians treating patients with SLE should consider that BENLYSTATM may increase the risk of PML.
GlaxoSmithKline Inc. has sent a letter to healthcare professionals informing them of this new safety information. Further information can be found on the Canadian website of GlaxoSmithKline (www.gsk.ca) or on the Health Canada Web site (www.healthycanadians.gc.ca/index-eng.php).
If you have questions regarding your BENLYSTATM prescription, please contact your doctor.
Managing marketed health product-related side effects depends on health care professionals and patients reporting them. Any case of PML or other serious or unexpected side effects in patients receiving BENLYSTATM should be reported to GlaxoSmithKline Inc. or Health Canada.
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Original signed by
Dr. Sally Taylor
Country Medical Director, Canada
TMBENLYSTA is a trademark of GlaxoSmithKline IP Limited.
SOURCE: GlaxoSmithKline Inc.
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