Important information note agreed with the Italian Medicines Agency following a European procedure, which provides healthcare professionals with information on the introduction of new warnings on the medicinal product in solution containing the stabilizing agent chlorbutanol regarding preclinical studies on potential cardiotoxic effects. The note
31 MAR –
Issued by the Italian Medicines Agency (Aifa) a Note intended for healthcare professionals with information on the introduction of new warnings on the drug Minirin/DDAVP (desmopressin) 50mcg/ml nasal spray, solution containing the stabilizing agent chlorbutanol. The product, containing the active ingredient desmopressin, is indicated for the treatment of: pituitary, idiopathic or symptomatic diabetes insipidus; post-surgical, reversible or permanent polyuria and polydipsia and for the differential diagnosis of diabetes insipidus and renal function tests.
Minirin/DDAVP 50mcg/ml nasal spray, solution – communicates the company – contains the stabilizing agent chlorbutanol. There are no human data from controlled studies on the pharmacological/toxicological effects of chlorobutanol. Preclinical in vitro cardiotoxicity studies and postmarketing safety data from intravenous formulations containing chlorbutanol indicate that chlorbutanol has the potential to prolong the QT interval; this may lead to a risk of arrhythmia, particularly in synergy with other substances that prolong the QT interval. In addition, preclinical in vitro and in vivo studies have demonstrated that repeated high doses of chlorbutanol can cause reproductive toxicity. It is not known to what extent chlorbutanol is absorbed following nasal administration but, if completely absorbed, the estimated exposure exceeds the permissible daily exposure limit of 0.5 mg/day.
To avoid potential harmful effects following exposure to chlorbutanol, the use of Minirin/DDAVP 50mcg/ml Nasal Spray should only be considered in situations where alternative formulations of desmopressin are not suitable for use. Ferring SpA – recalls the company – has been marketing nasal desmopressin formulations containing chlorbutanol for 40 years and in this period has not encountered any safety problems regarding cardiotoxicity or reproductive toxicity. However, based on published data, post-marketing data and preclinical studies of intravenous formulations containing chlorbutanol, the product information has been updated as a precaution to reflect the potential effects of the excipient chlorbutanol. Finally, Healthcare Professionals are reminded to continue to report suspected adverse reactions associated with the use of desmopressin in accordance with the national spontaneous reporting system, through AIFA.
March 31, 2023
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