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Australia: Safety advisory: Dolutegravir - new study suggests possible risk of birth defects (English Only)
 
The Therapeutic Goods Administration (TGA) announces that it is closely monitoring the safety of dolutegravir after preliminary results from a new study suggested risk of birth defects in babies born to women being treated with this medicine. In the meantime, dolutegravir should not be used in women seeking to become pregnant.

The preliminary results of the Tsepamo Study, conducted in Botswana, identified a potential risk of neural tube defects in babies born to women with exposure to dolutegravir-containing regimens at the time of conception. The Tsepamo study, which looked at babies born to 11,558 HIV-infected women, showed that 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a neural tube defect, such as spina bifida. This compared with 0.1% of babies (14 of 11,173) whose mothers took other HIV medicines. No cases were reported in infants born to women who started dolutegravir later during pregnancy. Final results from the study are expected in about a year.

While this issue is being investigated, dolutegravir should not be used in women seeking to become pregnant and women who can become pregnant should use effective contraception while taking it. Women who have been prescribed dolutegravir should not stop taking their medicine without first consulting their doctor.

The TGA will be working with ViiV Healthcare (the sponsor of dolutegravir) to update Product Information accordingly and further information will be communicated as appropriate.

Please refer to the following website in TGA for details: http://www.tga.gov.au/alert/dolutegravir

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 were not related to birth defects.

Related news was previously issued by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and was posted on the Drug Office website on 19 May 2018. Letters to inform local healthcare professionals of the above safety information were issued by the DH on 21 May 2018. The DH will keep vigilant on any further update from the FDA, EMA, TGA and other health authorities for consideration of any action deemed necessary.

Ends/Friday, Jun 1, 2018
Issued at HKT 15:00
 
Related Information:
European Union: PRAC confirms precautionary advice on HIV medicine dolutegravir ... 上載於 2018-10-06
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
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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