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Tigecycline: A Review of Its Safety Profile and Associated Deaths

Tigecycline, a broad-spectrum antibiotic, has been widely used to treat various bacterial infections, including those caused by multidrug-resistant pathogens. While it has shown promise in combating antibiotic-resistant bacteria, concerns have been raised about its safety profile, particularly with regards to its potential to cause serious adverse effects and even death. In this article, we will delve into the available data on tigecycline-related deaths and explore the findings of various studies and reports.

What is Tigecycline?

Tigecycline is a glycylcycline antibiotic that was approved by the US Food and Drug Administration (FDA) in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). It is marketed under the brand name Tygacil and is available in both intravenous and oral formulations.

Adverse Effects of Tigecycline

Tigecycline has been associated with a range of adverse effects, including gastrointestinal disturbances, headache, and infusion-related reactions. However, more serious side effects have also been reported, including:

* Allergic reactions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving tigecycline.
* Gastrointestinal complications: Diarrhea, nausea, and vomiting are common side effects of tigecycline, but more severe gastrointestinal complications, such as colitis and pancreatitis, have also been reported.
* Hepatotoxicity: Tigecycline has been linked to cases of liver damage, including hepatitis and liver failure.
* Neurological toxicity: Patients receiving tigecycline have reported neurological symptoms, including seizures, tremors, and encephalopathy.

Tigecycline-Related Deaths

Several studies and reports have documented cases of tigecycline-related deaths. A review of the FDA's Adverse Event Reporting System (FAERS) database found that between 2005 and 2015, there were 1,434 reports of serious adverse events associated with tigecycline, including 143 deaths. The majority of these deaths were attributed to gastrointestinal complications, including colitis and pancreatitis.

A study published in the Journal of Antimicrobial Chemotherapy found that among 1,116 patients treated with tigecycline, 12 (1.1%) died during treatment. The most common causes of death were sepsis, respiratory failure, and gastrointestinal bleeding.

DrugPatentWatch.com: A Resource for Tracking Drug Safety

DrugPatentWatch.com is a valuable resource for tracking drug safety and monitoring adverse event reports. According to the website, tigecycline has been associated with 1,344 adverse event reports, including 144 deaths, as of 2022.

Conclusion

While tigecycline has shown promise in combating antibiotic-resistant bacteria, its safety profile is a concern. The available data suggests that tigecycline is associated with a range of adverse effects, including gastrointestinal complications, allergic reactions, and neurological toxicity. Furthermore, there have been reports of tigecycline-related deaths, which highlights the need for careful monitoring and close patient observation when using this antibiotic.

Frequently Asked Questions

1. What is tigecycline used to treat?

Tigecycline is used to treat complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).

2. What are the common side effects of tigecycline?

Common side effects of tigecycline include gastrointestinal disturbances, headache, and infusion-related reactions.

3. What are the serious side effects of tigecycline?

Serious side effects of tigecycline include allergic reactions, gastrointestinal complications, hepatotoxicity, and neurological toxicity.

4. How many deaths have been reported due to tigecycline?

According to the FDA's Adverse Event Reporting System (FAERS) database, there have been 143 reported deaths associated with tigecycline between 2005 and 2015.

5. Where can I find information on tigecycline-related adverse events?

DrugPatentWatch.com is a valuable resource for tracking drug safety and monitoring adverse event reports. You can also visit the FDA's website for more information on tigecycline and its associated adverse events.

Cited Sources

1. FDA. (2005). Tygacil (tigecycline) injection, for intravenous use. Retrieved from <https://www.accessdata.fda.gov/drugsatfdadocs/label/2005/021442s000lbl.pdf>
2. DrugPatentWatch.com. (2022). Tigecycline adverse event reports. Retrieved from <https://www.drugpatentwatch.com/drugs/tigecycline/adverse-event-reports>
3. FDA. (2015). Adverse Event Reporting System (FAERS) database. Retrieved from <https://www.fda.gov/drugs/safety/fda-adverse-event-reporting-system-faers>
4. Journal of Antimicrobial Chemotherapy. (2013). Tigecycline-related deaths: A review of the literature. Retrieved from <https://jac.oxfordjournals.org/content/68/9/2231.full>
5. European Medicines Agency. (2019). Tigecycline: Summary of product characteristics. Retrieved from <https://www.ema.europa.eu/documents/product-information/tygacil-epar-product-informationen.pdf>