Drugs

Otsuka ICU Recalls Mislabeled Potassium Chloride Injection

Otsuka ICU Medical has recalled (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap label was incorrectly printed as 10 mEq, creating a dosing error risk. The company says the error was due to a manufacturing issue. Because the overwrap conceals the inner label, users could mistakenly administer double the intended dose if they rely on the outer label, it says.

An overdose of potassium chloride can lead to hyperkalemia, a potentially life-threatening condition that can cause cardiac arrhythmias, paralysis, hypotension, or cardiac arrest, the company says. Patients most at risk include premature infants, those with renal impairment, cardiac conditions, or on potassium-sparing diuretics.

To date, Otsuka says no adverse events have been reported in connection with the mislabeled product.

Potassium chloride injection is used to treat potassium deficiency in patients who cannot take oral replacement. Because it is a highly concentrated formulation, the company emphasized that it must be administered slowly and with continuous cardiac monitoring.

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