Tivicay® (dolutegravir): Reports of neural tube defects

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Description:

There is a potential safety issue related to cases of Neural Tube Defects (NTD) in infants born to women who were treated with antiretroviral regimens containing dolutegravir at the time of conception. Unscheduled preliminary analysis of the Tsepamo Study, carried out in Botswana, revealed four (4) NTD cases out of 426 pregnancies on dolutegravir. However, no NTD cases were detected in infants born to women who started taking dolutegravir during pregnancy (after conception) [N= 0/2824].

While this safety signal is being evaluated further, the following recommendations have been issued:

 

A Direct Healthcare Professional Communication (DHPC) letter has been issued by GlaxoSmithKline Pharmaceutical Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for more information.