Drug Safety Classifications and Adverse Reaction Monitoring
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Fetal Drug Safety Classifications
Type A: These drugs show no apparent risk to the fetus and are considered safe.
Type B: There is no evidence of risk in humans; their use is acceptable during pregnancy.
Type C: Risk cannot be ruled out. These should only be used in situations where there is no other safer drug available.
Type D: There is positive evidence of human fetal risk. These are used only when the drug is needed to treat a serious illness or an extreme situation where no safer alternatives exist.
Type X: These are contraindicated in pregnancy or for women who may become pregnant.
Defining Serious Adverse Drug Reactions (RAM)
What constitutes a serious Adverse Drug Reaction (RAM)? A reaction is considered serious if it:
- Causes death.
- Is life-