Drugs

Ozempic Mental Health Issues Up: NPR

An NPR report says the European Medicines Agency is looking into the risk of thoughts of self-harm and suicidal thoughts associated with using Novo Nordisk’s Ozempic (semaglutide) and similar drugs. The diabetes drugs are being used off-label to promote weight loss. NPR says that FDA has not opened an investigation but says it is monitoring the situation.

“We continue to conclude that the benefits of these medications outweigh their risks when they are used according to the FDA-approved labeling,” spokesperson Chanapa Tantibanchachai said in an e-mail to NPR. The report says she also noted that Novo Nordisk’s weight-loss drug Wegovy (semaglutide) includes a Warning about suicidal thoughts on its label.

NPR says it analyzed the FDA Adverse Event Reporting System (FAERS) and found 489 reports of patients experiencing anxiety, depression, or suicidal thoughts while taking semaglutide drugs. In 96 of the reports, the network says, the patient had suicidal thoughts, and five of them died. NPR says it is not known if the drugs caused the mental health problems. FAERS can flag questions, but isn’t designed to answer them, it says.

Previous clinical studies of the drugs provide little information, the report says, because trial participants with mental health issues tended to be weeded out from the studies.

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