A Hospira sales aid promoting Voluven for treating and preventing hypovolemia makes numerous unsubstantiated efficacy and comparative claims and downplays the drug’s risks, an FDA untitled letter states. The agency took issue with claims that broaden the drug’s indication by including cardiac pump priming and major abdominal surgery. Those are not mentioned in FDA-approved prescribing information (PI) for Voluven (6 percent hydroxyethyl starch in 0.9 percent sodium chloride injection), the agency said in the letter dated Dec. 16, 2011, and posted on its website Wednesday.
Washington Drug Letter