FDA flags trial deaths and ultrasound risk as studies map preventable harm

Safety concerns led this week’s digest: the FDA flagged four deaths in a schizophrenia drug trial and a potentially high-risk issue with Philips Lumify ultrasound equipment. Research also pointed to preventable cardiovascular deaths, major causes of childhood hospital deaths and prescribing problems linked to drugmaker payments.

Key developments

Deaths trigger schizophrenia trial safety signal

The FDA flagged a potential safety signal after four patient deaths in a trial testing a schizophrenia drug. Whether the treatment caused the deaths has not been established.

The deaths raise an unresolved safety question about the treatment being tested, not about schizophrenia drugs as a whole.

Oct 9 · STAT

Early alert for Lumify ultrasound equipment

The FDA issued an early alert about a potentially high-risk issue involving Philips Ultrasound’s Lumify transducers. Philips issued a letter, and the FDA said it would update the public as significant information becomes available.

The alert makes equipment-specific safety instructions relevant to clinicians using Lumify transducers.

Oct 9 · CDRH New - News and Updates | FDA

Blood-pressure care’s potential death toll reduction

Effective high-blood-pressure management could prevent more than 518,000 cardiovascular deaths annually across 20 countries, according to preliminary research presented at the American Heart Association’s Hypertension Scientific Sessions 2026.

The estimate puts a concrete potential mortality benefit on better hypertension care, though the conference findings remain preliminary.

Oct 11 · Medical Xpress

Malaria leads deaths in very young children

A prospective study found malaria was the leading cause of hospital admission and in-hospital death among children under two in Sierra Leone. Respiratory infections and diarrhea were also leading causes.

Malaria prevention and treatment directly address the leading hospital burden identified for children in their first two years of life.

Oct 9 · Medical Xpress

Drugmaker payments linked to inappropriate prescribing

A new review found that gifts and payments doctors received from drugmakers increased inappropriate prescribing, likely contributing to higher health care costs.

Financial relationships with drugmakers can affect which medicines patients receive and how much their care costs.

Oct 9 · STAT

Also this week

Infectious disease

• Florida’s current dengue outbreak was described as the largest in any U.S. state in several decades. Medical Xpress

• A study of more than 700 people found distinct mouth and lung microbiomes in people with long COVID, with lung differences associated with respiratory, cognitive and digestive symptoms rather than established as their cause. Medical Xpress

Cancer treatment

• Radiation treatment for lung cancer was linked to a potentially higher risk of pulmonary hypertension, a condition that can lead to right-sided heart failure, although causation was not established. Medical Xpress

Neurodegeneration

• A second-generation experimental “hypoxia in a pill” rescued neurodegenerative phenotypes across distinct mouse models, with human safety and efficacy still unestablished. Proceedings of the National Academy of S

• A Finnish study found that people diagnosed with Alzheimer’s before 65 accumulated health problems particularly in the preceding five years, including more depression, dizziness, headaches, traumatic brain injuries and epilepsy than matched controls. Medical Xpress

What to watch

• Watch for the FDA’s next public update on the Philips Lumify transducer issue, which it says will come as significant information becomes available; no timing has been announced.