Drugs

FDA Strengthens TIRF Opioid Product REMS

FDA says it has taken steps to strengthen the Risk Evaluation and Mitigation Strategies (REMS) program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the drugs’ benefits continue to outweigh their risks. An agency statement says that despite the decline in the use of TIRF products in recent years, data have suggested that prescribing TIRF medicines still occurs in patients who are not opioid-tolerant.

“With this in mind, FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices,” the statement says. “These changes will also improve our ability to monitor for adverse events and ensure safe use of these medicines.”

The agency says the program has been strengthened to require:

prescribers to document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use;
outpatient pharmacies dispensing TIRF medicines to document and verify a patient’s opioid tolerance before dispensing;
require inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized; and
development of a new patient registry for use, along with other data sources, to monitor for accidental exposure, misuse, abuse, addiction, and overdose.

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