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
• DDAVP
• DDVP
• Minirin
• 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

If you or a loved one has been injured as a result of using desmopressin acetate, you may be entitled to receive compensation for your pain and suffering, and to defray any medical costs. Drug manufacturers are responsible for ensuring the safety and efficacy of their products before they are marketed to the general public. Failure to adequately measure any potential side effects or inform consumers and physicians of the risks associated with a given product is deemed negligent and grounds for personal injury litigation.

The law offices of Aylstock, Witkin, Kreis and Overholtz boast some of the most experienced personal injury attorneys Pensacola, Florida has to offer. Contact the lawyers of AKWO Law today at 888-255-2956 to learn more about your rights as a desmopressin acetate injury victim.