FDA Recommends Enhanced Leqembi Monitoring

FDA recommends increased monitoring for Alzheimer's patients on Eisai/Biogen's Leqembi due to brain swelling and bleeding risks. Requires MRI oversight.

The FDA just issued new safety recommendations for Eisai and Biogen's Alzheimer's drug Leqembi, calling for enhanced monitoring of patients due to ongoing concerns about brain swelling and bleeding risks. This isn't a full scale warning, but rather what the agency calls a "recommendation for increased vigilance"specifically urging physicians to conduct MRIs before the seventh infusion and then periodically throughout treatment. The agency's notice highlighted that while Leqembi remains on the market, they're observing "a higher than anticipated incidence of amyloid related imaging abnormalities (ARIA)" in real world use compared to clinical trial data. Dr. Teresa Buracchio from the FDA's Center for Drug Evaluation and Research noted, "While Leqembi represents an important treatment option, we believe the benefits require careful risk management through ongoing surveillance."

Digging into the technical details, the concern revolves around ARIA specifically ARIA-E (edema) and ARIA-H (microhemorrhages) which showed up in approximately 15% of clinical trial participants but appears to be occurring at slightly higher rates in post-market use. This new monitoring protocol isn’t just a simple suggestion. Here's the thing this new monitoring protocol is no small ask for patients. We're talking multiple MRIs: one within the first three months of starting treatment, another before the seventh infusion, and then repeating the scan every six months after that. But the real kicker, and what's really got the medical community talking, is the recommendation for additional scans any time a patient reports new neurological symptoms. We're talking headaches, sudden confusion, or vision changes triggering an immediate MRI. This is a huge operational shift. Most neurology practices aren't set up for this kind of frequent, symptom-driven imaging schedule. It's going to force a whole new level of coordination between the prescribing neurologist, the radiology department reading the scans, and the infusion center administering the drug. For already stretched-thin clinics, this isn't just an inconvenience it's a complete workflow overhaul that'll require new staffing and scheduling systems just to keep up.

The implications here are substantial for both providers and patients. For physicians, this means implementing entirely new monitoring workflows and potentially delaying treatments when ARIA is detected. For doctors, this means building entirely new monitoring systems from the ground up and possibly pausing treatments if brain swelling shows up on scans. For patients and their families, it translates to more time in waiting rooms and mounting MRI bills that insurance might not completely cover. Eisai’s medical director, Dr. Ivan Cheung, didn’t sugarcoat it he admitted this adds complexity but stood firm that strict monitoring is non-negotiable for safety and maintaining the drug’s positive risk-benefit balance. Alzheimer’s advocates are stuck in a tough spot: thrilled to have a promising treatment but worried that extra hurdles could make it even harder for vulnerable patients to get the care they need. As one neurologist from the Cleveland Clinic put it, "This isn't just about writing a prescription anymore. We're building an entire surveillance infrastructure around one medication."