Updates ·
Health notices · Wednesday 16 September
3 notices from the agencies today, in plain words, each with the original linked.
FDA Class II alert for Broadway Joe's Pain Cream due to possible contamination
FDA · Recall
The US Food and Drug Administration issued a Class II alert for Broadway Joe's Pain Cream because of potential contamination of raw material.
This product was distributed in Colorado. If you have it, the main issue is safety related to possible contamination, not how it relieves pain.
FDA approved spironolactone and hydrochlorothiazide tablets
FDA · Approval
If you have fluid swelling from congestive heart failure, liver cirrhosis with fluid/ascites, or nephrotic syndrome, this FDA approval adds a new tablet option for those situations when other treatments aren’t enough or aren’t tolerated.
If you have essential hypertension (high blood pressure), this FDA approval includes its use to lower blood pressure when other measures are inadequate or inappropriate.
The label says to use this medicine only in the specified conditions and avoid unnecessary use. It also explains spironolactone can be a tumorigen in rat chronic toxicity studies, with risks discussed under precautions.
What to do
- Use spironolactone and hydrochlorothiazide tablets only for the conditions described in the label and avoid unnecessary use.
FDA approval of RASONQUE for metastatic pancreatic adenocarcinoma
FDA · Approval
If you are an adult with metastatic pancreatic adenocarcinoma, the US Food and Drug Administration has approved RASONQUE (daraxonrasib). Metastatic means the cancer has spread to other parts of the body.
RASONQUE is for people who have received at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy. Systemic therapy means treatment that works throughout the body.
RASONQUE is a RAS GTPase family inhibitor. An inhibitor is a medicine that blocks a specific target to help treat cancer. Ask your clinician whether it could be an option for you.
What to do
- Ask whether RASONQUE could be an option for you based on your prior treatments.