FDA Warns of Desmopressin Acetate Side Effects
The Food and Drug Administration has asked for a label update for all formulations of desmopressin acetate. This includes the intranasal formulation and tablet form of the drug, both of which have been linked with serious side effects.
Desmopressin acetate was developed to mimic vasopressin, a type of naturally-occurring antidiuretic hormone that inhibits the immoderate loss of water through urine. Synthetic vasopressin in the form of desmopressin acetate has often been prescribed as a solution to primary nocturnal enuresis (PNE), a bed-wetting disorder. However, recent studies have linked desmopressin – specifically the intranasal formulation – with serious and potentially life threatening side effects.
Desmopressin Side Effects and the FDA
Desmopressin has been linked with the potential development of severe hyponatremia and seizures. Hyponatremia is a condition in which the sufferer experiences abnormally low levels of sodium in their blood. Moderately low levels of sodium in the blood can cause cellular malfunction, and exorbitantly low levels can lead to death. Children are at an increased risk of developing desmopressin side effects.
An FDA study evaluated 61 seizure cases related to hyponatremia (two of which resulted in death). Of the 61 cases, 36 were linked with the intranasal formulation. Of these 36, 25 were children. Based on the results of the study, the FDA has suggested that intranasal desmopressin no longer be used for the treatment of PNE, and has requested that all desmopressin formulations include a warning alerting consumers to the hyponatremia and seizure risk associated with use of the drug.
Desmopressin formulations are marketed in a variety of ways, including:
- DDAVP Nasal Spray
- DDAVP Rhinal Tube
- Stimate Nasal Spray
Patients currently taking any of the aforementioned desmopressin formulations are advised to consult with their physician to determine an appropriate course of action.
Desmopressin Acetate Lawsuits
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by defective drugs. Contact AWKO law today at (844) 794-7402 to get more information about your rights as a Desmopressin Acetate injury victim.