Tygacil (generic: tigecycline) is a broad-spectrum intravenous antibiotic intended for the treatment of several bacterial infections that target the skin and the digestive system. Indications also suggest that Tygacil may assist in the treatment of pneumonia as well. Unfortunately, the use of this revolutionary antibiotic has become synonymous with catastrophic complications. According to the U.S. food and Drug Administration (FDA), Tygacil treatment may coincide with an increased mortality rate.
If you or a loved one has been injured by Tygacil, you should contact our lawyersimmediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Tygacil Lawsuit Overview
As a product of Wyeth Pharmaceuticals, Tygacil was introduced to the U.S. market on June 15, 2005. The revolutionary antibiotic became the first in a class of intravenous antibiotics intended to treat a broad-spectrum of infections. Tygacil was approved by the FDA to be used as an empiric monotherapy to treat several complicated skin infections, intra-abdominal infections and community acquired pneumonia.
Tigecycline, the active ingredient in Tygacil, resides in a group of medications known as glycylcycline antibiotics. As a glycylcycline antibiotic, Tygacil’s mechanism of action prohibits the bonding of aminoacyl-tRNA to the mRNA-ribosome complex. Subsequently, these actions prevent protein translation in bacteria and inhibit the spread of contaminated cells.
Unfortunately, the pharmacodynamics of glycylcycline antibiotics may also subject patients to a variety of complications with varying degrees of severity. Recent studies suggest that the use of Tygacil may coincide with a significantly increased mortality rate. Due to the severe nature of Tygacil complications, patients may contact a Tygacil lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Tygacil lawsuit.
The following is a comprehensive list of side effects that have been associated with the use of Tygacil:
- Injection site inflammation
- Abnormal Stool
- Taste perversion
While these side effects may not prove to be life-threatening, they may indicate more severe complications. An increased mortality rate has been associated with the use of Tygacil. Because of this catastrophic complication, Wyeth’s failure to provide a sufficient warning label may result in patients filing a Tygacil lawsuit.
FDA Tygacil Study
The FDA has reminded the healthcare community of an increased mortality risk associated with the use of Tygacil when compared to that of comparable drugs used to treat serious infections. The increased risk was determined after officials pooled data from several clinical studies. According to 13 trials in which patients received Tygacil, death occurred in 4.0% (150/3788) of patients, while 3.0% (110/3646) of patients receiving comparator antibiotics suffered from fatal complications.
FDA Tygacil Warning
In 2010, the FDA requested that the developers of Tygacil update the Warnings and Precautions section of their labels to indicate the increased rate of mortality. The following FDA Safety Alert acknowledged the dangers associated with receiving Tygacil treatment:
The FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. The FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.
Tygacil Public Citizen Petition
Public Citizen has suggested that the previous label change issued by the FDA in 2010 was insufficient in acknowledging the increased mortality rate of Tygacil. According to a petition issued by Public Citizen, the FDA should place a “black box” warning on Tygacil because of a higher mortality rate associated with taking the drug than other widely used antibiotics.
According to Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, “ the approximately 30 percent higher rate of mortality in subjects receiving tigecycline, as well the significantly higher rates of failures to cure serious infections, in comparison to subjects treated with comparator antibiotics, the content and placement of the warnings in the current drug label are woefully insufficient.”
Subsequently, Public Citizen has requested that the FDA add a “black box” warning to the labels of Tygacil packaging that warns of the increased risk of death. Furthermore, the consumer watchdog group has called for an additional warning to indicate that Tygacil should only be used as a last-resort in association with more antibiotics.
Do I Have a Tygacil Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Tygacil lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Tygacil, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.