The nurse is discussing a medication with a patient. This approved medication is discovered to have serious problems. Which FDA response does the nurse expect?
1. Require the medication to have additional clinical trials conducted.
2. Issue a warning to practitioners to watch for side effects in clients taking the drug.
3. Continue to monitor the medication in post-marketing studies.
4. Require that the drug be withdrawn from the market and its use discontinued.
Correct Answer: 4
Rationale 1: Require the medication to have additional clinical trials conducted is incorrect because the drug will be withdrawn from the market and its use discontinued.
Rationale 2: Issue a warning to practitioners to watch for side effects in clients taking the drug is incorrect because the drug will be withdrawn and its use discontinued.
Rationale 3: Continue to monitor the medication in post-marketing studies is incorrect because the drug will be withdrawn from the market and its use discontinued.
Rationale 4: The FDA requires that the drug be withdrawn from the market and its use discontinued.
Global Rationale: The FDA requires that the drug be withdrawn from the market and its use discontinued. Require the medication to have additional clinical trials conducted is incorrect because the drug will be withdrawn from the market and its use discontinued. Issue a warning to practitioners to watch for side effects in clients taking the drug is incorrect because the drug will be withdrawn and its use discontinued. Continue to monitor the medication in post-marketing studies is incorrect because the drug will be withdrawn from the market and its use discontinued.
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