其 他 安 全 警 示
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| The United Kingdom: Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that updated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Evidence collected as more women have given birth while on dolutegravir treatment shows a smaller increased risk than previously thought, almost comparable to other HIV drugs. The previous restrictions against use in pregnancy are no longer in place.
In Jun 2018, preliminary results from an observational study suggested an increased risk of neural tube defects in infants born to women who took dolutegravir at the time of conception. While a review of this signal was ongoing, MHRA issued a Drug Safety Update article asking healthcare professional not to prescribe dolutegravir to women who are trying to become pregnant. The product information for dolutegravir was amended with these recommendations and a letter was sent to healthcare professionals by the manufacturer.
The study is ongoing and since the article in 2018, additional women were included in the continuing analysis. For a total of 19,361 babies born to women with HIV in Botswana, updated data showed 0.19% (95% CI 0.09–0.40) of babies (7 of 3,591) whose mothers became pregnant while taking dolutegravir had a neural tube defect, compared with 0.11% (0.07–0.17) of babies (21 of 19,361) whose mothers took other HIV medicines.
The latest review also investigated cases of birth defects in babies born to women who took dolutegravir during pregnancy reported from the Antiretroviral Pregnancy Registry with 660 women exposed to dolutegravir during pregnancy. These data do not indicate an increased risk of major birth defects associated with dolutegravir treatment (absolute risk difference of neural tube defects between dolutegravir and other HIV treatment at conception of 0.08 [95% –CI 0.03 to 0.30]). However, because of the rarity of the neural tube defects, these data are insufficient to completely rule out any risk. Changes will be made to product information advice to reflect the latest review of data.
The review of the study is ongoing. Further advice will be communicated as appropriate as important new information becomes available.
Advice for healthcare professionals:
- Counsel women of childbearing potential about the possible risk of neural tube defects with dolutegravir, including consideration of effective contraceptive measures.
- Discuss the benefits and the risks of continuing treatment with dolutegravir to women who are trying to become pregnant.
- If a pregnancy is confirmed in the first trimester while a patient is on dolutegravir, the benefits and risks of continuing dolutegravir versus switching to another antiretroviral regimen should be discussed with the patient, taking into account the gestational age and the critical time period of neural tube defect development.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/dolutegravir-tivicay-triumeq-juluca-updated-advice-on-increased-risk-of-neural-tube-defects
In Hong Kong, there are 4 registered pharmaceutical products containing dolutegravir, namely Tivicay Tablets 50mg (HK-63516), Triumeq Tablets (HK-64012), Juluca Tablets (HK-66018) and Dovato Tablets (HK-66511). All 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 neural tube 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 6 Oct 2018. Letters to inform local healthcare professionals of the risk of neural tube defects were issued by the DH on 21 May 2018. In Dec 2018, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the product insert should include the relevant safety information. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Oct 23, 2020
Issued at HKT 16:00
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