DILI is a major cause of drug withdrawals due to what characteristics?

• A. rarity and unpredictability
• B. high cost
• C. easy marketing
• D. glossary undefined

Answer: (A)

DILI leads to drug withdrawals mainly because it is rare and unpredictable in occurrence. In premarketing trials, serious liver injury events are uncommon, so the full risk may not become apparent until the drug is used in a much larger, more diverse population. The unpredictable, idiosyncratic nature of many DILI cases means that even drugs that appear safe in trials can cause severe hepatotoxicity in a small subset of patients, often unrelated to dose or duration. When such rare but potentially fatal outcomes surface after widespread use, regulators may withdraw the drug to protect public health.

The other options don’t fit because high cost isn’t the primary driver of withdrawals for DILI, easy marketing would actually reduce concern rather than cause withdrawal, and “glossary undefined” isn’t a meaningful characteristic related to safety signals or pharmacovigilance.