ADR that result in revision of patient information
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| Singapore: Recommendations for HLA-B*1502 genotype testing prior to initiation of carbamazepine in new patients |
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The Health Sciences Authority (HSA) announced that the Ministry of Health (MOH) would like to inform healthcare professionals that genotyping for the HLA-B*1502 allele prior to the initiation of carbamazepine (CBZ) therapy in new patients of Asian ancestry is now considered the standard of care. HSA will strengthen the local package inserts for this drug product to highly recommend HLA-B*1502 genotyping test. CBZ is indicated for the treatment of epilepsy and other conditions such as diabetic neuropathy, trigeminal neuralgia and bipolar disorders.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, there are twelve registered pharmaceutical products containing carbamazepine and are prescription-only medicines. Letter to inform healthcare professionals that carbamazepine induced Steven Johnson Syndrome and Toxic Epidermal Necrolysis are significantly more common in patients with a particular human leucocyte antigen (HLA) allele HLA-B*1502, which occurs almost exclusively in patients with ancestry across broad areas of Asia and urge them to report any adverse drug reaction related to the drug was issued on 7 May 2008. In view of HSA’s action, 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.
Ends/ Thursday, May 02, 2013
Issued at HKT 18:00
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