Anaphylactic reaction to the complex of rocuronium and sugammadex

The sugammadex-rocuronium complex can cause severe allergic reactions. Also in patients who are not allergic to one of the individual agents. This is not stated in the summary of product characteristics (SmPCs) of both drugs.

Rocuronium is a muscle relaxant used during surgery as an adjunct to general anaesthesia. Sugammadex is used at the end of surgery to counteract the muscle relaxant effect of rocuronium. This occurs because sugammadex binds to rocuronium creating a complex of the two substances.

Lareb report
Lareb received a report of a life-threatening allergic reaction in a patient who was given sugammadex at the end of surgery to stop the muscle relaxant effect of rocuronium. Two to three minutes after administration of sugammadex the patient developed severely low blood pressure, a rapidly beating heart and became short of breath. Over time the skin turned red. The patient was given continuous adrenaline for more than 24 hours before the allergic reaction disappeared. Investigations revealed that the patient was hypersensitive to the complex of rocuronium and sugammadex, but not to the individual drugs.

Proper investigations important
Rocuronium and sugammadex can both individually cause an allergic reaction. This is also stated in the SmPCs of these drugs. The SmPCs do not state that the sugammadex-rocuronium complex can also cause an allergic reaction. In case of an allergic reaction after administration of rocuronium and sugammadex it is important to test not only for hypersensitivity to the individual drugs, but also for hypersensitivity to the sugammadex-rocuronium complex. This is to prevent a person from having another allergic reaction in the future.

Action
Pharmacovigilance centre Lareb has shared this report with the Medicines Evaluation Board. In addition, this information will be shared with practising healthcare professionals.

Read more about the report here.