Voluntary recalls of certain desmopressin nasal sprays in the US
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Voluntary recalls of certain desmopressin nasal sprays in the US Ferring Pharmaceuticals US is voluntarily recalling all lots of three specific desmopressin nasal spray products due to possible superpotency issues, according to a US FDA notification. The recall involves DDAVP Nasal Spray 10 µg/0.1mL and Desmopressin Acetate Nasal Spray 10 µg/0.1mL (both indicated as antidiuretic replacement therapy, and for management of temporary polyuria and polydipsia after head trauma/surgery),* in addition to Stimate Nasal Spray 1.5 mg/mL (indicated for treatment of patients with haemophilia A with Factor VIII coagulant activity levels of >5%). In Ferring’s announcement about this recall, the company stated that during routine testing, "these products are being recalled due to superpotency or amounts of desmopressin higher than specified". The risks associated with higher-than-specified desmopressin levels include hyponatraemia (i.e. abnormally low sodium levels in the blood) – which could potentially lead to seizure, coma, and death. Ferring added that, to date, the company "has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray" and that "a single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed". This recall of certain desmopressin sprays is being conducted with the knowledge of the FDA, and Ferring US is notifying its distributors and wholesale customers by letter, asking them to check for any products they have that are impacted by this recall (and to return any unused products via the directions provided). * polyuria = excessive urination; polydipsia = excessive drinking due to thirst Ferring Pharmaceuticals US. Ferring US Issues Voluntary Nationwide Recall of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE Nasal Spray 1.5 mg/mL Due to Superpotency. Internet Document : 5 Aug 2020. Available from: URL: https://www.fda.gov/safety/recalls-market-withdrawals803498130 safety-alerts/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate
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Reactions 22 Aug 2020 No. 1818
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