FDA Boxed Warning Is Not Enough: HHT Experts Call for Further Action
Beyond the FDA Warning: HHT Experts Call for Greater Scrutiny of Injectafer
A new JAMA Viewpoint by Drs. Hanny Al-Samkari, Scott Olitsky, and Michael Auerbach draws attention to the serious risks associated with ferric carboxymaltose (FCM; Injectafer) and the need for greater awareness among healthcare professionals.
Following a successful Citizen Petition initiated by Cure HHT, the FDA added a boxed warning to Injectafer on September 1, 2026, addressing the risk of hypophosphatemia (low phosphate levels) and potentially severe complications.
While this marks a significant victory for patient advocacy, the authors argue that the warning does not go far enough. They highlight evidence of serious skeletal and metabolic complications associated with Injectafer and question its risk-benefit profile given the availability of alternative IV iron formulations with substantially lower risks of hypophosphatemia.
The Viewpoint calls attention to an important treatment safety issue, particularly for individuals with HHT who may require repeated iron infusions.