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European Union: PRAC confirms precautionary advice on HIV medicine dolutegravir (English Only)
 
The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) confirmed its precautionary advice issued earlier this year on the use of dolutegravir in pregnant women and women who can become pregnant. Women who can become pregnant should use effective contraception while taking dolutegravir. In addition, women should undergo pregnancy testing before starting treatment and the medicine should not be used during the first trimester of pregnancy unless there is no alternative.

The evaluation assessed preliminary results from a study which found cases of neural tube defects (birth defects of the brain and spinal cord) in babies born to mothers who used dolutegravir during pregnancy. As the study is still ongoing, a further assessment will be carried out once the final results become available next year.

Please refer to the following website in EMA for details: http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-october-2018

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 7 Sep 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 EMA'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/6 Oct 2018
Issued at HKT 14:00
 
Related Information:
The United States: FDA Drug Safety Communication: FDA to evaluate potential risk... 上載於 2018-09-07
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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