Drugs

FDA Says Divinity Products Destroys Kratom Supply

FDA says Divinity Products Distribution, Grain Valley, MS, has destroyed and recalled a large volume of kratom-containing dietary supplements it manufactured and distributed nationwide under three brand names. An agency news release says the company also agreed to stop selling all products containing kratom.

“Based on the scientific evidence of the serious risks associated with the use of kratom,” the release says, “FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to FDA to evaluate them based on the applicable regulatory pathway.”

The agency says it is unaware of any evidence of safety establishing that kratom or any compounds derived from it will reasonably be expected to be safe as a dietary ingredient. Additionally, it says, kratom should not be used to treat any medical conditions and should not be used as an alternative to prescription opioids. There are currently no FDA-approved therapeutic uses of kratom and FDA has evidence to show that there are significant safety issues associated with its use, the release says.

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