Coagulation dysfunction events associated with tigecycline: a real-world study from FDA adverse event reporting...

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Infectious Diseases

Background:

• Tigecycline is a broad-spectrum antibiotic frequently used for severe infections in critically ill patients.
• Limited clinical data exists on tigecycline-induced coagulation disorders.
• This study investigates the association between tigecycline and coagulation dysfunction.

Purpose of the Study:

• To analyze the association between tigecycline and coagulation dysfunction.
• To quantify the risk of coagulation disorders with tigecycline use.
• To compare tigecycline's risk profile with other antibiotics.

Main Methods:

• Utilized data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2005 to December 2020.
• Conducted disproportionality analysis using reporting odds ratios (ROR) to assess the association.
• Compared tigecycline with the full FAERS database and specific antibiotics (vancomycin, daptomycin).

Main Results:

• 223 reports linked tigecycline to coagulation dysfunction, with 80.72% occurring within 14 days of initiation.
• A significant overall reporting odds ratio (ROR) of 3.55 (3.08, 4.09) was found for coagulation dysfunction.
• Specific risks included hypofibrinogenemia (ROR 705.41), prolonged aPTT (ROR 42.98), and coagulopathy (ROR 30.67).

Conclusions:

• A strong signal indicates a high frequency of coagulation dysfunction associated with tigecycline.
• Healthcare professionals must be vigilant for potential coagulation disorders during tigecycline treatment.
• Close monitoring of coagulation parameters, especially fibrinogen levels, is crucial.