Safety Alerts
Intravenous iron preparations and risk of allergic reactions
Audiences
Healthcare professional
Industry member
Product type
Therapeutic Products
29 August 2013
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Intravenous (IV) iron preparations provide an alternative treatment for iron deficiency in patients who are unable to take iron supplements by mouth, or when oral iron supplements have not been effective. Although the risk of allergic or hypersensitivity reactions with IV iron is rare, these reactions could become serious or fatal if not managed promptly.
Background
There are two IV iron preparations registered in Singapore, which contain complexes of a polynuclear iron-hydroxide core bound to other molecules. Iron sucrose 20mg/mL (Venofer®) is indicated for the treatment of iron deficiency in patients who cannot tolerate or are non-compliant to oral iron therapy, in active inflammatory bowel disease where oral iron preparations are ineffective, or where there is a clinical need for a rapid iron supply. Iron carboxymaltose 50mg/mL (Ferinject®) is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Both products are licensed by Vifor Pharma Asia Pacific Pte Ltd.
In June 2013, the European Medicines Agency (EMA) concluded that IV iron preparations continue to be beneficial, and released new recommendations to minimise the risk of allergic reactions with these preparations.1 EMA's review of these products was initiated at the request of the French health authority (ANSM), which had reported serious allergic reactions, especially in pregnant women who had received IV iron preparations.
Review by the EMA
Based on its review on IV iron preparations used to treat iron deficiency and anaemia, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended several measures to allow for the early detection and effective management of allergic reactions that might occur.1 This included advice that IV iron preparations should only be given in the presence of staff trained to evaluate and manage anaphylactic reactions in an environment with resuscitation facilities, as well as a reminder that caution is warranted with every dose of IV iron that is given, even if previous administrations had been well tolerated.
The CHMP also recommended that IV iron preparations should be avoided during pregnancy unless clearly necessary.1 In such cases, treatment should be confined to the second or third trimester, provided the benefits of treatment clearly outweighed the risks to the foetus, such as anoxia and foetal distress.
Local situation
Between 2002 and July 2013, HSA has received 20 local ADR reports associated with the use of IV iron sucrose or carboxymaltose preparations, of which 15 were related to allergic or hypersensitivity reactions, including one case of anaphylactic reaction. A further 14 reports were received for iron sucrose where the administration route was not specified. The majority of these reports also involved allergy-type reactions.
HSA is working with the company to strengthen the safety information in the local package inserts of IV iron preparations, including advice on monitoring and management of hypersensitivity reactions related to these products.
HSA's advisory
Healthcare professionals are reminded that all IV iron preparations can cause serious and potentially fatal hypersensitivity reactions. The risk of hypersensitivity is increased in patients with known allergies or immune or inflammatory conditions, as well as in patients with a history of severe asthma, eczema or other atopic allergy. Healthcare professionals are advised to adhere to the following precautions:1
Physician vigilance is advised with every dose of IV iron that is administered. There are data indicating that allergic reactions may still occur even if previous doses were well tolerated.
IV iron preparations should only be administered in the presence of staff trained to evaluate and manage anaphylactic reactions in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each administration. If hypersensitivity reactions or signs of intolerance occur, treatment must be stopped immediately and appropriate measures taken to handle such reactions.
IV iron preparations should be avoided during pregnancy. If clearly necessary, treatment should be confined to the second and third trimester. In many cases, iron deficiency anaemia occurring in the first trimester can be treated with oral iron.
Healthcare professionals are also encouraged to report adverse reactions suspected to be associated with the use of IV iron preparations to the Vigilance Branch of HSA.