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Review of fluvoxamine safety database
W Wagner1, B Plekkenpol, T E Gray
1Solvay Pharmaceuticals Inc., Marietta, Georgia.
Drugs
|January 1, 1992
Summary
Fluvoxamine safety was evaluated in 24,624 patients. Most common side effects were digestive and nervous system related, with nausea being most frequent. Serious adverse events and suicidality were low.
Area of Science:
- Psychiatry
- Pharmacology
- Clinical Trials
Background:
- Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) used to treat depression.
- Understanding its safety and tolerability profile in a large, diverse patient population is crucial for clinical practice.
Purpose of the Study:
- To review the safety and tolerability of fluvoxamine in worldwide marketing studies.
- To identify the incidence and types of adverse experiences and serious adverse events associated with fluvoxamine treatment.
Main Methods:
- A review of safety and tolerability data from worldwide marketing studies.
- Involved 24,624 patients, predominantly treated for depression in uncontrolled studies.
- Data analyzed by COSTART body system for adverse experiences.
Main Results:
- The most frequent adverse experiences affected the digestive (24.1%) and nervous (23.7%) systems.
- Nausea (15.7%) was the only adverse experience >10%. Somnolence (6.9%) and asthenia (6.2%) were also common.
- 15.1% discontinued treatment due to adverse events. Serious adverse events occurred in 2.5%, and overall suicidality in 0.8%.
Conclusions:
- Fluvoxamine demonstrates a generally acceptable safety and tolerability profile in a large patient cohort.
- Adverse experiences are predominantly mild to moderate, with low rates of serious events and suicidality.
- Nausea is the most common adverse event, necessitating monitoring and management.