Drugs

FDA Increasing Oversight on Diethylene Glycol Contamination

In response to a World Health Organization (WHO) warning about contaminated medications, including children’s cough/cold syrups found in Gambia with unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG), CDER director Patrizia Cavazzoni says the agency is stepping up its actions to prevent contaminated drug products from entering the U.S. market.

WHO has announced that cases of DEG and EG contamination have been reported in at least seven countries, with over 300 associated deaths. “This current outbreak is becoming one of the largest epidemics of DEG poisoning in history,” Cavazzoni observes in an online post.

“We have implemented strict safeguards to prevent DEG/EG adulterated products, including those listed in the WHO alerts, from being imported into the U.S., and we are also working with the Centers for Disease Control and Prevention (CDC), regulatory authorities in other countries, and the WHO to support investigation efforts to determine the root cause of the reported contamination,” she said. “We are closely scrutinizing multiple liquid formulations of FDA-regulated drug products, including syrups, solutions, and suspensions, made with glycerin, propylene glycol, polyethylene glycol, maltitol solution, hydrogenated starch hydrolysate, or sorbitol solution.”

Additionally, Cavazzoni said FDA has contacted drug product manufacturers to remind them about testing raw materials and finished product batches before release to ensure that a product is safe for use. She also cited a guidance entitled Testing of Glycerin for Diethylene Glycol to help drug makers test for potential contaminants.

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