Drugs

Ferring Recalls Desmopressin Due to Superpotency Concerns

Ferring Pharmaceuticals has recalled all lots of DDAVP (desmopressin) nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate (desmopressin) nasal spray 1.5 mg/mL. The products are being recalled due to superpotency concerns, an out-of-specification result detected during routine testing. “The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could eventually lead to seizure, coma, and death,” a recall notice says. “A single non-fatal adverse event potentially associated with this issue was reported in the U.S. during the timeframe that the affected product was distributed.”

DDAVP and Desmopressin Acetate Nasal Spray are indicated as antidiuretic replacement therapy in managing central cranial diabetes insipidus and for managing temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Stimate is indicated for treating patients with hemophilia A with Factor VIll coagulant activity levels greater than 5%, and for treating patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome