Other safety alerts
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| Singapore: Antibody-Mediated Pure Red Cell Aplasia (PRCA) case cluster observed with subcutaneous administration of erythropoietin (EPO) Eprex® at a Singapore Institution |
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The Health Sciences Authority (HSA) announced that Janssen, a division of Johnson & Johnson Pte Ltd (“Janssen”), is informing healthcare professionals of an increase in the number of EPO antibody-mediated PRCA cases with onset in 2012 and 2013 observed from one institution in Singapore. These cases comprise a cluster of 6 Eprex® reports and were reported in patients who had received subcutaneous administration of Eprex® at some point during their treatment. Janssen wishes to reinforce the vigilance for, and identification of, EPO antibody-mediated PRCA and the appropriate storage and handling of Eprex® that is described in the Singapore prescribing information.
Please refer to the following website in HSA for details:http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are 9 registered pharmaceutical products containing epoetin alfa (a type of erythropoietin). The nine products are prefilled syringe of Eprex 1000 (HK-39774), Eprex 2000 (HK-39775), Eprex 3000 (HK-39781), Eprex 4000 (HK-39776), Eprex 5000 (HK-49846), Eprex 6000 (HK-49847), Eprex 8000 (HK-49848), Eprex 10000 (HK-39783) and Eprex 40000 (HK-50971), which are registered by Johnson & Johnson (Hong Kong) Ltd. and are prescription only medicines.
Johnson & Johnson (Hong Kong) Ltd. has already contacted the Department of Health (DH) for the incident and the DH will keep vigilance against any safety updates of the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/Saturday, June 22, 2013
Issued at HKT 12:00
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