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The Food and Drug Administration (FDA) Drug Safety Communication and the Department of Health and Human Services (HHS) Antiretroviral Guidelines Panel issued the attached letter regarding the potential risk of the antiretroviral medication dolutegravir (DTG) associated with neural tube birth defects. 

For more information and to view the recommendations, visit the AIDSinfo website

Dolutegravir is used in combination with other antiretroviral drugs and is available as a single agent under the brand name, Tivicay, and as part of combination tablets with other antiretrovirals under the brand names, Juluca and Triumeq.

In response to the FDA alert, interim guidance was issued by the HHS Antiretroviral Guidelines Panels regarding dolutegravir (DTG). On May 30, 2018, the HHS Antiretroviral Guidelines Panels issued these recommendations to elaborate on their previous statement of May 18, 2018, and to continue to support the related FDA Drug Safety Communication.