158. A new medicinal drug is found to be effective but also carries a significant risk of a rare, severe adverse event. What critical ethical consideration guides its approval and prescribing?
A.
Only efficacy matters.
B.
The balance between benefits and harms, and informed consent for patients.
✓
C.
Adverse events are always acceptable.
D.
Only the cost of the drug matters.
📖 Additional Information
Only efficacy matters.
The balance between benefits and harms, and informed consent for patients.