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U.S. Department of Health and Human Services

Safety

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Luvox (fluvoxamine maleate) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Other Potentially Important Drug Interactions
    • Warfarin and Other Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, etc.)
  • Abnormal Bleeding

PATIENT COUNSELING INFORMATION

  • Concomitant Medication

WARNINGS AND PRECAUTIONS

Other Potentially Important Drug Interactions: Warfarin and Other Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, etc.)

Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Thus, patients should be cautioned about the use of such drugs concurrently with fluvoxamine...

Abnormal Bleeding

SSRI’s and SNRI’s, including Luvox Tablets, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRI’s and SNRI’s have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.

Patients should be cautioned about the risk of bleeding associated with the concomitant use of Luvox Tablets and NSAID’s, aspirin, or other drugs that affect coagulation [see section 5.7].