Which term refers to a medication that was withdrawn due to discovered toxicity?

Which term refers to a medication that was withdrawn due to discovered toxicity?

• A. Labeled Indications
• B. Benoxaprofen
• C. Expedited Approval
• D. Treatment INDs

Answer: (B)

Benoxaprofen is the real-world example of a drug pulled from use after toxicity was discovered. It was initially approved for inflammatory conditions, but post-marketing reports of serious liver injury led to its worldwide withdrawal to protect patients. This kind of action—removing a medication from the market due to safety concerns—is distinct from labeling for approved uses, expedited approval pathways, or programs that provide access to investigational drugs. The other choices describe those regulatory concepts, not the withdrawal of a drug because of toxicity.

Benoxaprofen is the real-world example of a drug pulled from use after toxicity was discovered. It was initially approved for inflammatory conditions, but post-marketing reports of serious liver injury led to its worldwide withdrawal to protect patients. This kind of action—removing a medication from the market due to safety concerns—is distinct from labeling for approved uses, expedited approval pathways, or programs that provide access to investigational drugs. The other choices describe those regulatory concepts, not the withdrawal of a drug because of toxicity.