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The United Kingdom: Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception (English Only)
Medicines and Healthcare products Regulatory Agency (MHRA) announces that new safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.

An EU review has begun following preliminary results from an observational study suggesting an increased risk of neural tube defects in infants born to women who took dolutegravir at the time of conception. The study, which looked at babies born to 11,558 women with HIV in Botswana, showed that 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a neural tube defect, 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 of the study are expected in about a year. The review will also investigate cases of birth defects in babies born to women who took dolutegravir during pregnancy reported, including two in the USA.

A Direct Healthcare Professional Communication has been sent to healthcare professionals involved in the care of patients with HIV and to patient groups in the UK to advise of these recommendations. The European Medicines Agency has issued information to patients.

Further advice will be communicated as appropriate at the end of the review.

Healthcare professionals are advised:
- do not prescribe dolutegravir to women who are trying to become pregnant
- exclude pregnancy in women of childbearing potential with pregnancy testing before starting dolutegravir
- advise women of childbearing potential to use effective contraception throughout treatment with dolutegravir
- if pregnancy is confirmed in the first trimester while a woman is taking dolutegravir, switch to an alternative treatment unless there is no suitable alternative
- advise any women taking dolutegravir for HIV to not stop taking their medicine without first consulting their doctor
- report any suspected adverse drug reactions associated with dolutegravir to the Yellow Card Scheme

Please refer to the following website in MHRA for details:

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 various overseas drug regulatory authorities, and was posted on the Drug Office website since 19 May 2018, with the latest update posted on 8 Jun 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 these health authorities for consideration of any action deemed necessary.

Ends/Saturday, Jun 23, 2018
Issued at HKT 13:00
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
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