Drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk for potentially dangerous side effects. It is the strongest warning because of their appearance in a drug label.

Paper handouts that are available with many prescription medicines. These guides address issues specific to particular drugs + drug classes, contain FDA-approved information that can help patients avoid serious adverse events.

A system used by the FDA to describe five levels of assessment of fetal effects caused by a drug.

Pregnancy Categories (category A)

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (no evidence of risk in later trimesters).

Pregnancy Categories (category B)

Animal reproduction studies have failed to demonstrate a risk to the fetus, & there are no adequate & well-controlled studies in pregnant women.

Pregnancy Categories (category C)

Animal reproduction studies have shown an adverse effect on the fetus & there are no adequate & well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pregnancy Categories (category D)

There is positive evidence of human fetal risk based on the adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pregnancy Categories (category X)

Studies in animals or humans have demonstrated fetal abnormalities &/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience & the risk involved in use of the drug in pregnant women.

Special Labeling and Record-Keeping Considerations: Patient Package Inserts

Certain drugs that require additional, manufacturer provided information be given to a patient because of the possibility of adverse effects from the medication; interactions between food, drugs, or supplements; and teratogenicity to an unborn fetus.

Veterinary Medications: "Caution:..."

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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10.1.25 Ch. 2

Terms & Definitions.

Term	Definition
Boxed Warning	Drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk for potentially dangerous side effects. It is the strongest warning because of their appearance in a drug label.
MedGuides	Paper handouts that are available with many prescription medicines. These guides address issues specific to particular drugs + drug classes, contain FDA-approved information that can help patients avoid serious adverse events.
Pregnancy Categories	A system used by the FDA to describe five levels of assessment of fetal effects caused by a drug.
Pregnancy Categories (category A)	Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (no evidence of risk in later trimesters).
Pregnancy Categories (category B)	Animal reproduction studies have failed to demonstrate a risk to the fetus, & there are no adequate & well-controlled studies in pregnant women.
Pregnancy Categories (category C)	Animal reproduction studies have shown an adverse effect on the fetus & there are no adequate & well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Categories (category D)	There is positive evidence of human fetal risk based on the adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Categories (category X)	Studies in animals or humans have demonstrated fetal abnormalities &/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience & the risk involved in use of the drug in pregnant women.
Special Labeling and Record-Keeping Considerations: Patient Package Inserts	Certain drugs that require additional, manufacturer provided information be given to a patient because of the possibility of adverse effects from the medication; interactions between food, drugs, or supplements; and teratogenicity to an unborn fetus.
Veterinary Medications: "Caution:..."	Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Repackaging
Drug Enforcement Administration Verification Alpha Characters & meanings
Risk Management Programs for Prescription Drugs
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Created by: user-1970435

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