MedWatch is an FDA program for reporting “serious reactions” resulting from a prescription medication.
The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes:
- Patient’s Death: when adverse reaction to drug is the suspected cause of death
- Life-Threatening Condition: serious side-effect put patient at real risk of dying
- Hospitalization: admitted because of serious adverse reaction to medication
- Permanent Disability: strokes; nervous system disorders; other impairment
- Birth Defect or Birth with Disease: congenital anomaly; adverse outcome to child
- Needs Medical Intervention to Avoid Permanent Damage: medical treatment required