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FDA Warns Of Possible Birth Defects From Dolutegravir HIV Drug

(May 22, 2018, 11:01 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on May 18 issued a drug safety communication that the HIV drug dolutegravir, sold as Tivicay, Juluca and Trimeq, has been associated with neural tube birth defects in an African observational study.

The FDA said the neural tube defects involve the brain, spine and spinal cord. 

The agency said the defects were reported in babies born to women treated with dolutegravir for the mother’s HIV infection.  The FDA said the preliminary results are from an observational study...
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