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European Union: New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir – While EMA review is ongoing, dolutegravir should not be used in women seeking to become pregnant (English Only)
 
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) is evaluating preliminary results from a study which found 4 cases of birth defects such as spina bifida (malformed spinal cord) in babies born to mothers who became pregnant while taking dolutegravir.

The study, which looked at babies born to 11,558 HIV-infected women 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. Final results are expected in about a year.
Women who have been prescribed dolutegravir should not stop taking their medicine without first consulting their doctor.

While EMA is assessing the new evidence it has issued the following precautionary advice:

- Dolutegravir HIV medicines should not be prescribed to women seeking to become pregnant.
- Women who can become pregnant should use effective contraception while taking dolutegravir medicines.

EMA will update the recommendations as necessary when it concludes its assessment.

Please refer to the following website in EMA for details:http://www.ema.europa.eu/../news_detail_002956.jsp&mid=WC0b01ac058004d5c1

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.

In view of EMA’s PRAC announcement, letters to inform local healthcare professionals of the above safety information will be issued. The DH will keep vigilant on any further update from the EMA and other health authorities.

Ends/ Saturday, May 19, 2018
Issued at HKT 12:00
 
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
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
The United States: FDA Drug Safety Communication: FDA to evaluate potential risk... 上載於 2018-05-19
 
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