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Health Canada, GSK update risks profile on Lupus drug Benlysta

Filed May 10th, 2012 Laurie

Health Canada has posted a safety warning about potential side effects caused by the lupus drug Benlysta.

According to an original announcement from GlaxoSmithKline Inc., patients taking Benlysta face a greater risk of developing hypertension (elevated blood pressure levels) and “infusion reactions.” Benylsta is approved to treat lupus in adults. A patient taking Benlysta is also taking another drug to treat the disease.

Warnings already included with prescriptions of Benlysta have some information on its potential risk of causing hypertension but the updated warning has more specifics on the risks: “BENLYSTA™ can cause a reaction to the infusion or an allergic (hypersensitivity) reaction. These can affect 1 to 10 users in 100, and can occasionally be severe, and can cause death. They are more likely to happen on the day of treatment, but can happen later.”

Any patients who have allergic reactions to other drugs should note this to their physician prescribing Benlysta. There are drugs available to reduce the risks of infections. Patients taking Benlysta should alert their doctors if they begin suffering from swelling of their face, lips, mouth, or tongue. Difficulty breathing, a rash or hives, light-headedness, a slowed heart rate and short breath are also early signs of hypertension likely caused by Benlysta.

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