The FDA announced on March 30 that the agency is intensifying a warning of potentially life-threatening allergic reactions caused by intravenous injection of nano-iron oxides to reflect the allergic reactions associated with the drug since its approval, including death.
When Feraeheme was approved in 2009, information on the risk of potentially life-threatening allergies was included in the warnings and precautions of the drug's prescription information, which is associated with all intravenous iron medications. However, since the approval of nano-iron oxide, "severe reactions including death have occurred, even if the treatment is rationally used to treat these reactions, and urgent measures have been taken," the FDA said.
The way to reduce this risk has been confirmed, “Medical professionals should follow the new recommendations in the drug label,” including new contraindications. “It is highly recommended not to use Feraheme for allergies to any intravenous iron substitute. The patient who responded," the statement said.
Other recommendations included in the new revised prescribing information include intravenous injection of diluted nano-iron oxide for at least 15 minutes, and should never be used without dilution; closely monitor signs and symptoms of severe allergic reactions in patients, including monitoring pulse during medication And blood pressure, monitor at least 30 minutes after each infusion; carefully consider the potential risks and benefits of this drug for elderly patients and patients with multiple drug allergy history, the severe allergic reaction in these two groups may increase.
Between June 2009 and June 2014, 79 cases of nano-iron oxide-related allergic reactions reported in the FDA's Adverse Event Reporting System database were confirmed to occur in 19-96 year old patients, 18 of which were fatal," Although medical interventions and emergency resuscitation attempts were made directly." About half of the cases occurred during the first dose, and 60 (about 75%) occurred during the infusion period or within 5 minutes after the completion of the complete infusion.
Of the 79 cases, 34 (43%) were reported to have a history of drug allergy; 24% had a history of multiple drug allergy. Cardiac arrest, hypotension, difficulty breathing, nausea, vomiting, and blushing are the most common symptoms.