18. During post-marketing surveillance, a new antibiotic shows a statistically significant increase in the incidence of a rare cardiac arrhythmia. What medicinal epidemiological implication is this?
A.
The drug should be immediately withdrawn from the market without further investigation.
B.
A signal has been detected, prompting further investigation, possibly leading to a black box warning or withdrawal.
✓
C.
The finding is likely due to chance and can be ignored.
D.
The drug is still safe for all patients.
📖 Additional Information
The drug should be immediately withdrawn from the market without further investigation.
A signal has been detected, prompting further investigation, possibly leading to a black box warning or withdrawal.
The finding is likely due to chance and can be ignored.
