EMA examines warnings of anaphylactic reactions to Rienso

9 May 2014

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started two new safety reviews at its May meeting.

The PRAC provided an update to an ongoing review of Rienso (ferumoxytol) from Japanese drug maker Takeda (TYO: 4502) including global reports of serious anaphylactic reactions with the medicine. Rienso is used to treat anemia in patients with long-term kidney disease. While the review is on-going, the attention of healthcare professionals is being drawn to the existing risk minimization measures and warnings for anaphylactic reactions included in Rienso’s product information.

Review of hydroxyzine-containing medicines started

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