Drugs

Safety Alert on Pediatric Cough Drops

FDA has issued a safety alert on over-the-counter G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, manufactured by Novis PR LLC, because they may contain the incorrect product and cause patient harm. “Novis received multiple complaints from pharmacies that found the wrong product – Finafta Anesthetic/Analgesic Liquid – inside the carton packaging of the G-Supress product,” the alert says. The Finafta product contains 60% ethyl alcohol and 5% benzocaine.

“Infants and young children are at higher risk of developing alcohol toxicity, profound hypoglycemia (low blood sugar), coma, hypothermia (low body temperature), or death from ingesting even relatively small amounts of ethanol,” the agency says. “Benzocaine can cause methemoglobinemia, a potentially life-threatening condition where too little oxygen is delivered to your cells.”

Novis has issued a recall of Lot D20911 (expiry 10/25) of G-Supress, the alert says, and it has not received any reports of adverse events or injuries related to product use.

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