FDA Drug Risk Classification

Which FDA Drug Risk Classification Category?
Controlled studies in humans show no risk to the fetus

A

Which FDA Drug Risk Classification Category?
No controlled studies have been conducted in humans; animal studies show no risk to the fetus

B

Which FDA Drug Risk Classification Category?
No controlled studies have been conducted in animals or humans

C

Which FDA Drug Risk Classification Category?
Evidence of human risk to the fetus exists; however, benefits may outweigh risks in certain situations

D

Which FDA Drug Risk Classification Category?
Controlled studies in both animals and humans demonstrate fetal abnormalities; the risk in pregnant women outweighs any possible benefit

X

What Pregnancy Category?
Safe

A

What Pregnancy Category?
Prescribed only as needed for maternal health

B

What Pregnancy Category?
Prescribed only in pregnancy if benefit clearly outweigh the risks

C

What Pregnancy Category?
Not recommended in pregnancy; prescribed if absolutely necessary

D

What Pregnancy Category?
Absolute Contraindication

X

Drugs under Pregnancy Category A?

Levothyroxine, Folic Acid

Drugs under Pregnancy Category B?

Metformin, Hydrochlorothiazide

Drugs under Pregnancy Category C?

Tramadol, Gabapentin

Drugs under Pregnancy Category D?

Alprazolam, Clonazepam

What Drugs under Pregnancy Category X?

Warfarin, Methotrexate, Statins

Type of effect of ADR A?

Augmented

Type of effect of ADR B?

Bizzare

Type of effect of ADR C?

Chronic Use

Type of effect of ADR D?

Delayed

Type of effect of ADR E?

End of Use

Type of effect of ADR F?

Failure of Therapy

Characteristic of ADR A?

Dose-dependent (Predicted)

Characteristic of ADR B?

Dose-independent (Unpredictable)

Characteristic of ADR C?

Prolong treatment (Long term exposure)

Characteristic of ADR D?

After years of treatment

Characteristic of ADR E?

Occurs after withdrawal

Example of ADR A?

Hypoglycemia from insulin

Example of ADR B?

Anaphylaxis Aspirin-induced asthma

Example of ADR D?

Carcinogenesis

Example of ADR E?

Cushing syndrome after abrupt discontinuation of corticosteroids

Example of ADR F?

Pregnancy after using Oral contraceptive pills