Difference between revisions of "Adverse drug event"
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'''An adverse event''' is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is: | '''An adverse event''' is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is: | ||
− | Death | + | * Death |
− | Life-threatening | + | * Life-threatening |
− | Congenital Anomaly/Birth Defect | + | * Congenital Anomaly/Birth Defect |
− | Required Intervention to Prevent Permanent Impairment or Damage (Devices) | + | * Required Intervention to Prevent Permanent Impairment or Damage (Devices) |
− | Other Serious (Important Medical Events) | + | * Other Serious (Important Medical Events) |
== Important interactions == | == Important interactions == |
Revision as of 18:32, 17 November 2011
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:
- Death
- Life-threatening
- Congenital Anomaly/Birth Defect
- Required Intervention to Prevent Permanent Impairment or Damage (Devices)
- Other Serious (Important Medical Events)
Important interactions
Drug-drug interactions Drug-allergy interactions Drug-food interactions Drug-laboratory interactions Drug-tobacco interactions
References
- What is a Serious Adverse Event? FDA. [1]