Tygacil (tigecycline) is an intravenous antibiotic medication that works by inhibiting bacterial growth instead of directly killing bacteria. Although this is a good way to prevent development of antibiotic-resistant bacteria, there is evidence that Tygacil is less effective at treating infections than other antibiotics, and it has a higher risk of death. Our lawyers are now evaluating potential Tygacil lawsuits on behalf of people who were injured.
Need a Tygacil Lawyer? If you or your loved one was injured by Tygacil, contact our law firm immediately for a free case consultation. If you file a Tygacil lawsuit, you could receive compensation for your injury, medical expenses, and more.
What is Tygacil?
Tygacil (tigecycline) is an injection antibiotic created by Wyeth Pharmaceuticals (now part of Pfizer). It was approved by the FDA on June 15, 2005 for the treatment of complicated skin infections and intra-abdominal infections. Tygacil is the first drug in a new class of antibiotics called glycylcyclines, which inhibit bacterial growth by preventing protein synthesis. Its unique structure and mechanism of action make it less susceptible to the development of resistant bacteria.
Tygacil was fast-tracked through the FDA approval process because it showed effectiveness against antibiotic-resistant bacteria, which is a growing problem in hospitals. Tygacil has shown effectiveness against a broad spectrum of bacteria, including antibiotic-resistant infections like methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermis (MRSE), pennicillin-resistant Streptococcus pneumoniae, and vanomycin-resistant Enterococcus (VRE).
Tygacil Increases Risk of Death Compared to Other Antibiotics
In September 2013, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication and placed a “Black Box Warning” on the label for Tygacil to emphasize that it is associated with a higher risk of death than other antibiotics.
The FDA also issued a Safety Warning in August 2010 after linking Tygacil to an increased risk of death. According to the FDA, Tygacil’s mechanism of action (preventing bacterial growth instead of killing bacteria) may be less effective in treating infections.
Tygacil and Ventilator-Associated Pneumonia
Tygacil is sometimes used off-label to treat infections that have never been approved by the FDA, such as diabetic foot infections and ventilator-associated pneumonia. Tygacil is much less effective at treating these infections than other antibiotics, and patients have a significantly higher risk of death. According to the Prescribing Information (PDF):
- Patients with ventilator-associated pneumonia who were treated with Tygacil had a 47.9% cure-rate, compared to 70.1% for other treatments.
- Patients with ventilator associated pneumonia who were treated with Tygacil had a higher risk of death (19.1%) compared to 12.3% of patients who received other treatments.
In 2010, the FDA also warned:
“Mortality in Tygacil treated patients was numerically greater in every infection, sometimes considerably greater, particularly in ventilator-associated pneumonia. Tygacil is not approved for ventilator associated pneumonia because of an unacceptably low cure rate, as well as excess mortality.”
Clinical Studies of Tygacil Side Effects
In April 2006, researchers from Baylor University Medical Center published a study with this clear warning: “[Tygacil] should not be used for patients who are not at risk of resistant infections.”
Evidence of increased risk of death from clinical studies:
- An increase in all-cause mortality was observed in Phase 3 and 4 clinical trials involving Tygacil-treated patients versus comparator-treated patients.
- In 13 trials involving over 7,000 patients, death occurred in 4% of Tygacil patients and 3% of comparator-treated patients.
- In 10 clinical trials involving only Tygacil’s approved indications (complex skin infections and intra-abdominal infections), Tygacil was associated with a 2.5% risk of death, compared to 1.8% of comparator-treated patients.
- Patients treated with Tygacil had a higher risk of infection-related serious adverse events than patients given other antibiotics (7% versus 6%).
- 2% of patients treated with Tygacil developed sepsis/septic shock, compared to 1% of patients given other treatments.
Do I have a Tygacil Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Tygacil lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Tygacil Lawsuit Evaluation: Again, if you or a loved one was injured by Tygacil (tigecycline), you should contact our law firm immediately. You may be entitled to compensation by filing a Tygacil lawsuit and we can help.