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The Contraindications section of a package insert lists situations when a drug can be used.

A) True
B) False

User Davidson
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1 Answer

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Final answer:

The statement is false; the Contraindications section lists situations where a drug should not be used. It is important for safety and regulatory compliance to adhere to the approved indications and contraindications of a drug.

Step-by-step explanation:

The statement 'The Contraindications section of a package insert lists situations when a drug can be used' is false. Contraindications refer to specific situations where a drug should not be used because it could be harmful to the patient. Package inserts describe these contraindications to inform healthcare providers and patients about the circumstances under which the drug poses more risks than benefits. For example, a drug might be contraindicated for patients with a certain medical condition or while taking another medication due to potential dangerous interactions or adverse effects.

Drug advertising regulation mandates that a drug can only be advertised for indications approved by the FDA. A fair balance between the benefits and the risks of a drug is required in these advertisements. 'Off-label' refers to using a drug for an indication not approved by the FDA. Postmarket safety surveillance continues to monitor drugs after they have been approved to ensure their safety in broader patient populations.

User Tsouchlarakis
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