Drugs

No Evidence of Contaminated Cough Syrup in U.S.: FDA

FDA says there is no evidence at this time that contaminated cough syrup products that have killed more than 300 children in Asia and Africa have entered the U.S. supply. CBS News reports the agency gave the assessment while saying it is joining the World Health Organization (WHO) and other international partners in investigating the source of the contaminated cough syrups.

The over-the-counter cough syrup products sold in several countries are reportedly tainted with diethylene glycol and ethylene glycol, according to the WHO. Reuters reports that most of the children who died were under age 5 and the cause of death was acute kidney injury. The stated manufacturer of the products was Maiden Pharmaceuticals Limited of Haryana, India.

“Although FDA currently has no indication that the products described in the 2022 and 2023 WHO alerts have entered the U.S. drug supply, the agency is investigating the potential impact and scope of this hazard on FDA-regulated products,” the agency told CBS News. It said strict safeguards have been implemented so that products made with “glycerin, propylene glycol, polyethylene glycol, maltitol solution, hydrogenated starch hydrolysate or sorbitol solution” are receiving “increased regulatory oversight.”

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