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946 results
  • Analysis of Pharmacovigilance Databases for Dolutegravir Safety in Pregnancy. [Journal Article]
    Clin Infect Dis 2019van De Ven NS, Pozniak AL, … Hill A
  • CONCLUSIONS: Pharmacovigilance databases have many limitations, most importantly lack of a clear denominator for patients exposed to the drug of interest and duplicate cases that are difficult to identify. Given widespread use of new antiretroviral drugs worldwide and anticipated use of new drugs, prospective follow-up of pregnant women and birth surveillance studies such as Tsepamo are critically needed.Neural tube defects have been reported among infants born from women taking a wide range of antiretrovirals in 4 pharmacovigilance databases. Safety reports were inconsistent between databases and very hard to interpret.
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