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Comment & Response
September 19, 2017

Low-Dose Desmopressin Nasal Spray and FDA Approval—Reply

Author Affiliations
  • 1Division of Pharmacoepidemiology and Pharmacoeconomics, Harvard Medical School, Boston, Massachusetts
JAMA. 2017;318(11):1071-1072. doi:10.1001/jama.2017.11343

In Reply Drs Fein and Herschkowitz indicate that the pharmacokinetics of desmopressin nasal spray (Noctiva) mitigate the risk of hyponatremia while preserving efficacy. However, the drug was approved with a boxed warning, “Noctiva can cause hyponatremia, which may be life-threatening if severe.”1 This prominent FDA-required statement supports the contention that hyponatremia was still seen by the reviewers as an important risk from use of this medication.1 The authors also state that all 5 deaths in the desmopressin group were unrelated to the product, but this differs from the phrasing in the FDA report: “All deaths occurred among patients in the desmopressin group and none occurred in the placebo group, although 3 deaths were deemed by the FDA to be unrelated to the medication.”2