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# Warning on Neural Tube Birth Defects with Tivicay
- URL: https://www.fdaweb.com/warning-on-neural-tube-birth-defects-with-tivicay/
- Published: 2018-05-18T12:00:00.000Z
- Updated: 2026-09-15T00:06:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141481

FDA has issued a safety alert about serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Viiv Healthcare’s Tivicay) used to treat human immunodeficiency virus. “Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects,” an FDA [notice](https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm?ref=fdaweb.com) says.