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The United States: FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq): Update (English Only)
 
The US Food and Drug Administration (FDA) announces that, as an update in Sep 2018, the information regarding serious cases of neural tube birth defects involving the brain, spine, and spinal cord reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV) has been addressed in product labeling.

Please refer to the following website in FDA for details: http://www.fda.gov/Drugs/DrugSafety/ucm608112.htm

In Hong Kong, there are 2 registered pharmaceutical products containing dolutegravir, namely Tivicay Tablets 50mg (HK-63516) and Triumeq Tablets (HK-64012). Both products are registered by GlaxoSmithKline Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to dolutegravir, but these cases are not related to birth defects.

Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 19 May 2018, with the latest update posted on 23 Jun 2018. Letters to inform local healthcare professionals of the above safety information were issued by the DH on 21 May 2018. In light of the above FDA’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board. The DH will maintain vigilant on any further update from these health authorities for consideration of any action deemed necessary.

Ends/Friday, Sep 7, 2018
Issued at HKT 16:00

 
Related Information:
European Union: PRAC confirms precautionary advice on HIV medicine dolutegravir ... 上載於 2018-10-06
The United Kingdom: Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): signal of increa... 上載於 2018-06-23
Canada : New safety information for women using dolutegravir, a medication used ... 上載於 2018-06-08
Singapore : Important safety update on dolutegravir (TIVICAY/ TRIUMEQ): Neural t... 上載於 2018-06-05
Australia: Safety advisory: Dolutegravir - new study suggests possible risk of b... 上載於 2018-06-01
Safety alerts on the risk of birth defects with the HIV medicine Dolutegravir by... 上載於 2018-05-21
European Union: New study suggests risk of birth defects in babies born to women... 上載於 2018-05-19
The United States: FDA Drug Safety Communication: FDA to evaluate potential risk... 上載於 2018-05-19
 
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