New Safety Recommendation for Ferumoxytol, EMA Says

Mark Crane


July 11, 2014

To better manage the risk for serious hypersensitivity reactions, ferumoxytol should be given by infusion over the course of at least 15 minutes, instead of by injection, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended this week.

The benefits of ferumoxytol still outweigh the risks, but the drug should be contraindicated in patients with any known history of drug allergy, the PRAC said in a release.

At the time of ferumoxytol's approval, studies had found that serious cases of hypersensitivity or hypotension were uncommon, seen in just 0.2% of patients. It is unclear whether more cases were discovered or whether the committee simply found increased benefits in terms of infusion reducing hypersensitivity over injection.

Ferumoxytol is used to treat anemia in patients with chronic kidney disease. The drug is branded as Rienso in Europe and Feraheme in the United States.

In January this year, the US Food and Drug Administration declined to approve an expanded use for ferumoxytol in patients with adult iron deficiency anemia who have failed or cannot tolerate oral iron treatment.

The new administration recommendation came after PRAC concluded its regular benefit–risk assessment of ferumoxytol. Periodic Safety Update Reports (PSURs) are reports providing an evaluation of the benefit–risk balance of a medicine. They are submitted by marketing authorization holders at defined points after a medicine's authorization.

During PSUR assessments, the PRAC evaluates any new risks identified for a medicine to assess whether its balance of benefits and risks has changed. The committee can then decide whether further investigations need to be carried out, or they can recommend action to protect the public from the risks identified.


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