Desmopressin (Nocutil, Minirin)
The active ingredient desmopressin (contained in various preparations) is approved for the treatment of primary enuresis nocturna, for the treatment of vasopressin-sensitive central diabetes insipidus, and for the treatment of nocturia associated with nocturnal polyuria in adults.
The German Federal Office for Safety in Health Care recalls that the intranasal use of desmopressin for the therapy of enuresis nocturna in children has not been approved throughout Europe since 2007 for safety reasons.
Measures at EU level
Desmopressin is a synthetic analog of the hormone arginine vasopressin, but compared to the natural hormone, the duration of the antidiuretic effect is considerably prolonged.
The active ingredient desmopressin is available in oral and nasal dosage forms. The nasal forms of administration have a higher bioavailability than the oral formulations. This - in conjunction with a certain dosage vagueness with nasal application - can lead to the occurrence of overdoses, especially in children, characterized by hyponatremia, water intoxication, and associated brain edema and seizures. Life-threatening events have also been reported in this context.
In 2007, this led to a reassessment of the benefit/risk ratio and the withdrawal of the indication enuresis nocturna for all nasally applicable desmopressin-containing preparations on a pan-European level. Oral forms of therapy are available for the treatment of enuresis nocturna in children, and the indication diabetes insipidus was retained for desmopressin-containing nasal sprays.
Situation in Austria
In Austria, the following desmopressin-containing pharmaceutical specialties are approved for nasal administration:
- Desmopressin Actavis 0.1 mg/ml nasal spray.
- Desmopressin Gebro 0.1 mg/ml nasal spray
- Minirin 0.1mg/ml nasal spray
- Nocutil 0.1mg/ml nasal spray
- Octostim 1.5 mg/ml nasal spray
BASG has received 39 case reports of the occurrence of hyponatremia, water intoxication, and seizures associated with nasal use of desmopressin in children up to the time of indication withdrawal.
BASG recommendations for users:
- Desmopressin in oral form is approved for the treatment of primary enuresis nocturna in children five years of age and older after organic causes have been ruled out and when other, non-drug therapeutic measures have been unsuccessful.
- Users are urged to follow the recommendations of the valid professional information - especially with regard to use in children.
- Use outside of approved indications is strongly discouraged.
BASG recommendations for patients:
- Patients are urged to follow the advice given in the valid package leaflet.
