Drugs

FDA Orders Immediate-Release Opioid Label Changes

FDA says it is requiring class-wide safety labeling changes for immediate-release (IR) opioid pain medications, including a new Boxed Warning about the serious risks of misuse, abuse, addiction, overdose, and death. An agency news release says that FDA also is requiring several additional safety labeling changes across all prescription opioid products including additional information on their risks.

An updated IR opioid indication clarifies that because of their treatment risks, the drugs should be reserved for pain severe enough to require opioid treatment for which alternate treatment options such as non-opioid analgesics or opioid combination products are inadequate or not tolerated. The dosing information also provides clearer instructions about patient monitoring and drug administration, FDA says, including initial dosage, dosage changes during therapy, and a warning not to abruptly stop treatment in a physically dependent patient.

As part of the IR opioid analgesic Boxed Warning, the agency now requires a Precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated using protocols developed by neonatology experts.

The updated labeling for all opioids (both extended-release/long-acting and IR) will include safety information about potentially harmful drug interactions with other medicines that can result in serotonin syndrome. It also will include information about opioid effects on the endocrine system, including adrenal insufficiency and androgen deficiency.

FDA says that it is aware of and carefully reviewing available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once that review is completed, it says, the agency will take necessary actions to ensure that prescribers and the public are informed of the risks involved with using those medications.

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