Drugs

FDA Cautions About Compounded Ketamine

FDA says there is increased interest in compounded ketamine products, including oral formulations, for treating psychiatric disorders. An online post says patients and healthcare providers should know:

ketamine is not approved by the agency to treat any psychiatric disorder because it has not determined that the products are safe and effective for use to treat disorders such as depression, anxiety, post-traumatic stress disorder, and obsessive-compulsive disorder;
compounded drugs are not FDA approved, meaning the agency has not evaluated their safety, effectiveness, or quality before marketing, and thus compounded drugs do not have any FDA-approved indications or routes of administration;
using compounded ketamine products without monitoring by a healthcare provider for sedation, dissociation, and changes in vital signs may put patients at risk for serious adverse events;
known safety concerns associated with using ketamine products include abuse and misuse, psychiatric events, increases in blood pressure, respiratory depression, and lower urinary tract and bladder symptoms;
despite increased interest in using compounded ketamine, FDA is not aware of evidence to suggest that it is safer, is more effective, or works faster than medications that are FDA-approved to treat certain psychiatric disorders.

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