Updates ·
Health notices · Saturday 31 October
3 notices from the agencies today, in plain words, each with the original linked.
FDA approval for VERQUVO (vericiguat) for certain chronic heart failure
Food and Drug Administration (FDA) · Approval
If you have symptomatic chronic heart failure with an ejection fraction below 45%, the US FDA has approved VERQUVO (vericiguat). Ejection fraction is the heart’s pumping function measured in percent.
VERQUVO is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization after a recent heart-failure hospitalization or a need for outpatient IV diuretics.
What changes for you: this is a new treatment option indicated to lower the chance of dying from cardiovascular causes and needing hospital care for worsening HF.
Ashwagandha capsules recalled due to potential Salmonella contamination
CDC · Food safety
If you bought 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha Capsules (120 count), check whether they are from lot 2025-26227.
The Centers for Disease Control and Prevention reports the lot is being recalled because it has the potential to be contaminated with Salmonella, an organism that can cause serious illness.
FDA approval of Talzenna for certain breast and prostate cancers
FDA · Approval
If you have adult HER2-negative locally advanced or metastatic breast cancer with a harmful (or suspected harmful) germline BRCA change, the FDA has approved TALZENNA.
If you have HRR gene-mutated metastatic castration-resistant prostate cancer, the FDA approval includes TALZENNA used with enzalutamide, where appropriate.
For both uses, the label says doctors should select who gets TALZENNA based on an FDA-approved companion diagnostic, to match the required gene change.
What to do
- Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.