Other safety alerts
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| European Union: New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines |
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has completed its review of intravenous iron-containing medicines used to treat iron deficiency and anaemia (low red blood cell counts) associated with low iron levels. The CHMP concluded that the benefits of these medicines are greater than their risks, provided that adequate measures are taken to minimise the risk of allergic reactions.
Intravenous iron medicines are used when iron supplements given by mouth cannot be used or do not work. All intravenous iron medicines have a small risk of causing allergic reactions which can be life-threatening if not treated promptly. The Committee therefore concluded that measures should be put in place to ensure the early detection and effective management of allergic reactions that may occur. Iron preparations should only be given in an environment where resuscitation facilities are available, so that patients who develop an allergic reaction can be treated immediately. In addition, the CHMP considered that the current practice of first giving the patient a small test dose is not a reliable way to predict how the patient will respond when the full dose is given. A test dose is therefore no longer recommended but instead caution is warranted with every dose of intravenous iron that is given, even if previous administrations have been well tolerated.
The CHMP also considered that, during pregnancy, allergic reactions are of particular concern as they can put both the mother and unborn child at risk. Intravenous iron medicines should therefore not be used during pregnancy unless clearly necessary. Treatment should be confined to the second or third trimester, provided the benefits of treatment clearly outweigh the risks to the unborn baby. The Committee also recommended further activities, including yearly reviews of allergic reaction reports and a study to confirm the safety of intravenous iron medicines. The CHMP recommendation will now be sent to the European Commission for the adoption of a legally binding decision throughout the EU.
Detailed recommendations for patients and healthcare professional are available at the link below.
http://www.ema.europa.eu/../news_detail_001833.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 6 registered intravenous iron-containing pharmaceutical products indiciated to treat iron deficiency or anaemia (low red blood cell counts) associated with low iron levels. The six products are Venofer Inj 100mg/5ml (HK-50860), Sucrofer Inj 20mg/ml (HK-56025), Ferrovin Inj 20mg/ml (HK-56858), Monofer Solution for Injection/Infusion 100mg/ml, 500mg/5ml and 1000mg/10ml (HK-61624, HK-61625 and HK-61623). In view of the findings by EMA, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The Drug Office of Department of Health will remain vigilant on new safety information related to intravenous iron-containing medicines issued by other regulatory authorities.
Ends/ Saturday, June 29, 2013
Issued at HKT 17:00
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