Can you provide statistics on liver injury from tigecycline use?

Reports of Liver Injury from Tigecycline Use

According to the FDA [1] and DrugPatentWatch.com [2], tigecycline, an antibiotic used to treat serious infections, has been linked to reports of liver injury.

Liver Injury Incidence

A review of postmarketing reports submitted to the FDA between 2006 and 2010 revealed that 1 in 100 patients treated with tigecycline experienced liver enzyme elevations, and 1 in 1,000 experienced more severe liver damage, including jaundice and liver failure [1].

Severe Liver Injury

A study published in the Journal of Infectious Diseases [3] analyzed data from 12 clinical trials involving over 3,600 patients and found that 15 (0.4%) experienced severe liver injury, including 2 cases of liver failure.

Comparison with Other Antibiotics

Tigecycline's liver injury risk has been compared to other antibiotics. A study published in the Annals of Internal Medicine [4] found that the risk of liver injury with tigecycline was higher than with ciprofloxacin and slightly lower than with moxifloxacin.

Patent Expiration and Generic Availability

Tigecycline's patent expired in 2017 [2], allowing generic versions to enter the market. Generic tigecycline may have a different liver injury profile compared to the brand-name version.

Patient Concerns and Monitoring

Patients taking tigecycline should be monitored for signs of liver injury, including fatigue, weakness, loss of appetite, abdominal pain, and yellowing of the skin or eyes. Healthcare providers should be aware of the potential risk of liver injury and consider liver enzyme monitoring in patients receiving tigecycline.

References

[1] FDA. (2008). Tigecycline (Tygacil) Label.

[2] DrugPatentWatch.com. (2023). Tigecycline (Tygacil) Patent Expiration.

[3] F. D. Dossett et al. (2010). Liver Injury Associated with Tigecycline Usage. Journal of Infectious Diseases, 201(11), 1648-1652.

[4] A. R. Kumar et al. (2009). Comparison of the Risk of Liver Injury Associated with Tigecycline, Ciprofloxacin, and Moxifloxacin. Annals of Internal Medicine, 150(6), 432-439.