Drugs

Petition Seeks Carbetocin OK for Postpartum Hemorrhage

Two physicians affiliated with Stanford University’s medical school are urging FDA to approve carbetocin for preventing postpartum hemorrhage, arguing that the drug could provide a longer-lasting alternative to currently available uterotonic medications.

In an 8/25 citizen petition, Kenneth Nguyen and Pervez Sultan asked FDA to approve carbetocin for use following both vaginal and cesarean deliveries. They also asked the agency to consider expedited regulatory pathways if appropriate.

Postpartum hemorrhage is a major cause of maternal illness and death worldwide. The petition says existing U.S. treatments, including oxytocin, methylergometrine, carboprost and misoprostol, can have limitations such as short duration of action, side effects, contraindications and the need for repeated doses.

The petitioners point to carbetocin's longer half-life — about 40 minutes compared with three to five minutes for oxytocin — and its single-dose administration as potential advantages. They cite randomized trials and systematic reviews that they say demonstrate carbetocin is noninferior or superior to oxytocin for preventing postpartum hemorrhage.

Carbetocin has already undergone regulatory review and is approved in several countries, including Canada, the United Kingdom, Australia, New Zealand, India and Singapore, according to the petition. The petition also cites World Health Organization evaluations of carbetocin for postpartum hemorrhage prevention.

The petition focuses particularly on heat-stable carbetocin, which does not require the same cold-chain infrastructure as conventional oxytocin. The physicians argue that this could reduce drug waste and storage and transportation costs associated with maintaining oxytocin at recommended temperatures.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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