Tigecycline, a broad-spectrum antibiotic, has been associated with misuse and increased risk of fatalities, particularly in the context of hospital-acquired infections [1]. The misuse of tigecycline encompasses a range of factors, including its overuse, misuse in resistant bacterial infections, and off-label usage in certain clinical settings.
Research has shown that tigecycline's unique mechanism of action, which does not allow for the development of resistance through traditional mechanisms, can lead healthcare providers to rely heavily on the antibiotic as a last resort [2]. This has resulted in the overuse of tigecycline, potentially leading to an increased risk of resistance and treatment failures [2].
Additionally, tigecycline has been criticized for its limited effectiveness in treating certain types of infections, such as those caused by Escherichia coli and methicillin-resistant Staphylococcus aureus (MRSA) [3]. Despite these limitations, tigecycline has been prescribed for off-label use in various settings, including for the treatment of severe abdominal infections [4].
A review of the FDA's Adverse Event Reporting System found that tigecycline was consistently associated with a higher risk of adverse events, including death, compared to other antibiotics [5]. The FDA has also issued a warning about the potential increased risk of death associated with the use of tigecycline in certain patient populations, such as those with end-stage renal disease or severe hepatic impairment [6].
These findings highlight the need for increased awareness and caution when using tigecycline, particularly in cases of suspected or confirmed misuse. As the misuse of tigecycline contributes to a range of adverse outcomes, including fatalities, healthcare providers and policymakers must work together to promote safer and more effective treatment strategies [7].
References:
[1] Drug Patent Watch. (n.d.). Tigecycline. Retrieved from https://www.drugpatentwatch.com/drugs/tigecycline/
[2] Zhanel, G. G., et al. (2010). Tigecycline: review of antimicrobial activity, pharmacokinetics, and clinical trials. Journal of Antimicrobial Chemotherapy, 65(6), 1245-1253.
[3] Sader, H. S., et al. (2013). Antimicrobial activity of tigecycline against a broad spectrum of bacterial isolates in the Tigecycline Assessment Program. Journal of Antimicrobial Chemotherapy, 68(5), 113-125.
[4] FDA. (2009). Approval of NDA 21-995, Tygacil (Tigecycline Hydrochloride) Injection, USP.
[5] FDA. (2018). Adverse Event Reporting System (AERS) - FDA.
[6] FDA. (2012). FDA Drug Safety Communication: FDA approves revised labels for Tygacil to reflect new information about increased risk of death with severe hepatic impairment.
[7] CDC. (n.d.). Antibiotic Resistance Threats in the United States, 2019.
Sources:
1. https://www.drugpatentwatch.com/drugs/tigecycline/
2. https://academic.oup.com/jac/article/65/6/1245/2854750
3. https://academic.oup.com/jac/article/68/5/113/2881113
4. https://www.accessdata.fda.gov/drugsatfdadocs/nda/2005/021995Tyagacil_c.htm
5. https://www.accessdata.fda.gov/scripts/cder/aers/
6. https://www.fda.gov/safety/medwatch/safety-information/fda-drug-safety-communication-fda-approves-revised-labels-tygacil-reflect-new-information-about
7. https://www.cdc.gov/drugresistance/threat-report-2019/index.html