Tigecycline (Tygacil▼): increased mortality in clinical trials
- Medicines and Healthcare products Regulatory Agency
- 4 April 2011
- Therapeutic area:
- Infectious disease
Use only when other antibiotics are unsuitable
Article date: April 2011
Tigecycline is a glycylcycline antibiotic approved for the treatment of complicated skin and soft tissue infections and complicated intra-abdominal infections.
Results of pooled analysis
The licence holder for tigecycline completed a pooled analysis of results from all phase 3 and phase 4 trials in the approved indications (complicated skin and soft tissue infections and complicated intra-abdominal infections). Death occurred in 2.3% (52 of 2216) patients receiving tigecycline and 1.5% (33 of 2206) patients receiving comparator drugs.
A larger analysis adding results from trials of tigecycline use in unapproved indications (diabetic foot infections, nosocomial pneumonia, and treatment of resistant pathogens) also showed numerically higher overall mortality rates in patients treated with tigecycline versus those treated with active comparators.
The cause of these findings is unknown. The possibility that tigecycline has a poorer efficacy and/or safety profile than the comparator drugs cannot be excluded. Patients who develop superinfections, particularly nosocomial pneumonia, seem to be at particular risk of having a poor outcome, including death.
Advice for healthcare professionals includes:
- tigecycline is approved only for treatment of complicated skin and soft tissue infections and complicated intra-abdominal infections
- tigecycline should only be used in situations where it is known or suspected that other drugs are unsuitable
- numerically higher mortality rates have been reported in patients treated with tigecycline in clinical studies in approved and unapproved indications, compared with patients treated with other antibacterial agents
- patients who develop superinfections, particularly nosocomial pneumonia, seem to be at particular risk of having a poor outcome - patients should be closely monitored for the development of superinfections; if medically indicated, they should be switched to alternative antibiotic treatment which has been shown to be efficacious in the treatment of the specific infection present
- report suspected adverse reactions with tigecycline through the Yellow Card Scheme—see at http://www.yellowcard.gov.uk: when reporting, please provide as much information as possible, including information about medical history, concomitant medication, and dates of treatment and reaction onset
BNF section 5.1.3: Tetracyclines (external link)
Article citation: Drug Safety Update April 2011; vol 4 issue 9: A1
Published: 4 April 2011
Therapeutic area: Infectious disease