Health Canada Issues Warning for Benlysta Hypersensitivity and Infusion Reactions

Health Canada Issues Warning for Benlysta Hypersensitivity and Infusion ReactionsCanadian regulator, Health Canada, has just issued a warning for lupus medication, Benlysta, over hypersensitivity and infusion reactions.

Benlysta (belimumab) is a prescription drug approved for the treatment of adults diagnosed with lupus (systemic lupus erythematosus or SLE), who are also being treated with other medications for lupus.

When initially approved, Benlysta’s Product Monograph contained information and warnings about allergic (hypersensitivity) reactions occurring more often in patients treated with Benlysta, versus patients not treated with Benlysta, said Health Canada.

The Benlysta Product Monograph has been updated with the following information:

  • Benlysta can cause a reaction to the infusion or an allergic reaction, which can affect 1 to 10 users in 100, can occasionally be severe, and can cause death. Reactions are most likely to take place on the day of treatment, but can occur later.
  • Before receiving Benlysta, patients are advised to tell their healthcare provider if they experienced an allergic reaction to other drugs or shots and injections. Patients may be prescribed medicines to help prevent reactions before taking Benlysta.
  • Patients are advised to contact their physicians immediately if any of the following symptoms develop following Benlysta treatment: Swelling of the face, mouth, lips, or tongue, which can lead to breathing difficulties; rash, possibly with itchy raised bumps or hives; light-headedness upon standing, which can indicate low blood pressure; slow heart beat; and/or shortness of breath

GlaxoSmithKline advised healthcare professionals, by letter, of the new safety information.

To report suspected adverse reactions to these or other health products, please contact Health Canada’s Canada Vigilance Program—to report adverse health product reactions—can be reached, toll-free, at 1.866.234.2345, or at the MedEffect™ Canada Web site at:

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