What is Tygacil?
Tygacil (tigecycline) is an intravenous antibiotic that is used in hospital settings. It was developed by Wyeth Pharmaceuticals, now part of Pfizer Inc., and approved by the U.S. Food and Drug Administration (FDA) in 2005.
Tygacil was fast-tracked through the FDA approval process because it was hoped to be an effective treatment for antibiotic-resistant bacteria, such as penicillin-resistant Streptococcus pneumoniae, methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis (MRSE), and vancomycin-resistant Enterococcus (VRE).
How Does Tygacil Work?
Unlike traditional antibiotics, Tygacil works by inhibiting bacterial growth instead of directly killing bacteria. It stops the incorporation of amino acids into peptide chains, which prevents protein synthesis in each bacterial cell. This mechanism has a broad antibiotic effect and is unlikely to contribute to antibiotic resistance.
Tygacil Increases Risk of Death
Patients who are treated with Tygacil are about 30% more likely to die from their bacterial infection than patients who are treated with other antibiotics. Although no one knows exactly why this is the case, it is possible that inhibiting bacterial growth is simply less effective than directly killing bacteria when treating an infection. Tygacil is least effective when treating conditions that are not approved by the FDA, such as hospital-acquired pneumonia, ventilator-associated pneumonia, and diabetic foot infections.
FDA Safety Warning for Tygacil
In September 2010, the FDA published a Safety Announcement to warn about the increased mortality risk associated with Tygacil. The conclusions were based on an analysis of 13 clinical trials. Overall, death occurred in 4% of patients receiving Tygacil and 3% of patients receiving other antibiotics. Most of the deaths were caused by worsening infections, complications and underlying medical conditions.
According to the FDA:
“Mortality in Tygacil treated patients was numerically greater in every infection, sometimes considerably greater, particularly in ventilator-associated pneumonia.”
Mortality statistics for Tygacil:
- Cure rate for patients with ventilator associated pneumonia who were treated with Tygacil was 47.9%, compared to 70.1% for patients treated with other antibiotics.
- Death occurred in 19.1% of patients given Tygacil to treat ventilator-associated pneumonia, compared to 12.3% in patients who receive other treatments.
- Infection-related adverse events occurred in 7% of Tygacil patients, compared to 6% of patients receiving other treatments.
- Sepsis / septic shock occurred in 2% of Tygacil patients, versus 1% of comparators.
Other Serious Tygacil Side Effects
- Allergic reactions
- Anaphylactic shock
- Acute pancreatitis (pancreas inflammation)
- Hepatic cholestasis (bile duct obstruction in liver)
- Jaundice (yellowing of skin, eyes)
- Skin reactions (Stevens-Johnson Syndrome)
Do I have a Tygacil Class Action 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 Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by Tygacil, you should contact our law firm immediately. You may be entitled to compensation by joining a Tygacil class action lawsuit or by filing a Tygacil lawsuit, and we can help.