Drugs

More Suicide Deaths Linked to FDA Antidepressant Warnings

Researchers representing several academic institutions worldwide say FDA’s Boxed Warning for youth antidepressants has not had the intended outcome of increased monitoring for suicidal thoughts and behaviors and instead is associated with unintended reductions in doctor visits for depression, depression diagnoses, antidepressant treatment and use, and psychotherapy visits, as well as increases in psychotropic drug poisonings and in suicide deaths. Writing in Health Affairs, the researchers say, “The overwhelming evidence suggests that the ongoing use of these Warnings may result in more harms than benefits.”

The authors call on FDA to review the totality of evidence and err on the side of caution in acknowledging the possible harms of the antidepressant Boxed Warnings.

“High-quality studies support reevaluation and possible replacement of the FDA Boxed Warning with routine Warnings in product labeling,” they conclude. “Moreover, such Warnings should be evaluated rigorously by independent scientists to yield objective evidence on their intended and unintended consequences.”

The researchers evaluated 11 studies conducted between 1/1/2003 and 10/31/2022.

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