Drugs

Hospira Recalls 1 Lot of Bacteriostatic Water

Hospira has recalled one lot (# W20308) of its bacteriostatic water for injection, USP, 30 mL, multi-dose vial due to sterilization concerns. “In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur,” a recall notice says. To date, Hospira says it has not received any adverse event reports associated with this issue. Bacteriostatic water is a sterile, nonpyrogenic preparation of water for injection containing 0.9% of benzyl alcohol added as a bacteriostatic preservative. It is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection.

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