Drugs

Safety Alert on ‘Mislabeled’ Paralyzing Agents

An FDA-issued safety alert warns health care professionals about the temporary absence of a “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents. Vecuronium bromide for injection 10 mg per vial and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL, 100 mg/10 mL, commonly used to provide muscle relaxation during surgery or mechanical ventilation, usually include a warning statement embossed on the vial cap to identify the product as a paralyzing agent, FDA says. Rocuronium bromide injection is marketed by Gland Pharma and Mylan, and vecuronium bromide injection is made by Gland Pharma Limited and distributed by Fresenius Kabi.

“The paralyzing agent warning statement assists health care professionals in clearly identifying neuromuscular blocking agents that produce muscle paralysis (including the muscles associated with breathing), and can cause significant patient harm, including death, when used in error,” the alert says. “These statements are required on the container closure under the FDA approval for these drugs.”

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

Read more

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