其 他 安 全 警 示
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| Singapore: Intravenous iron preparations and risk of allergic reactions (English Only) |
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Intravenous (IV) iron preparations can cause allergic or hypersensitivity reactions. Although rare, these reactions could become serious or fatal if not managed promptly. Between 2002 and July 2013, HSA has received 20 local reports associated with the use of IV iron preparations, of which 15 were related to allergic or hypersensitivity reactions, including one case of anaphylactic reaction. HSA is working with the product licence holders to strengthen the safety information in the local package inserts of Venofer® (iron sucrose) and Ferinject® (iron carboxymaltose). Healthcare professionals are reminded that physician vigilance is advised with every dose of IV iron that is administered, even if previous doses were well tolerated. In addition, IV iron preparations should only be administered in the presence of staff trained to evaluate and manage anaphylactic reactions in an environment with resuscitation facilities. They should also be avoided during pregnancy and confined to the second or third trimester if clearly necessary.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../intravenous_iron_preparations.html
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). Related news has been released by the EMA and was posted on the website of Drug Office on 29 June 2013. A letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 2 July 2013. As reported on 29 June 2013, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, August 30, 2013
Issued at HKT 12:30 |
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