Tygacil (generic: tigecycline) is a new antibiotic approved for treatment of severe, drug-resistant infections, especially skin infections, intra-abdominal infections, and community-acquired bacterial pneumonia. The FDA has recently found an increased risk of death, especially in patients treated for ventilator-associated pneumonia and diabetic foot infection, which are uses not approved by the FDA.
Do I have a lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping people who have been injured or wronged. If you or a loved one has taken Tygacil and has experienced a severe side effect, you should contact our Tygacil lawyers immediately. You may be entitled to compensation by filing a Tygacil lawsuit.
UPDATE: Black Box Warning for Increased Risk of Death Added to Tygacil Label
September 27, 2013 — The FDA has added a “Black Box Warning” to the label on Tygacil to warn that it may increase a patient’s risk of death compared to other antibiotics. The FDA recommends only using Tygacil if other antibiotics are not appropriate. Click here to read more.
June 6, 2012 — The consumer advocacy group Public Citizen is updating its petition calling for a “Black Box” warning on the label of Tygacil to warn of the increased risk of death. The updated petition will include new information from a scientfic study, which found Tygacil associated with a 0.7% increased risk of death, and a 2.9% increased risk of non-cure rates.
What is Tygacil?
Tygacil (tigecycline) a prescription medicine created by Wyeth Pharmaceuticals, owned by Pfizer Inc. It was approved for use in the U.S. in 2005 for the treatment of complex bacterial infections. The approval of this drug was exciting, because drug-resistant bacteria had become an increasing cause of death in many hospitals. Tygacil was fast-tracked through the FDA approval process because preliminary research showed that it was active against penicillin-resistant Streptococcus pneumoniae, methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis (MRSE), and vancomycin-resistant Enterococcus (VRE).
Tygacil is the first drug in a new class of antibiotics called glycylcyclines to receive FDA approval. Glycylcyclines are different from other antimicrobials, because rather than killing the bacteria directly, they inhibit bacterial growth by halting the incorporation of amino acids into the bacteria’s peptide chains. Initial results were exciting, because due to the unique structure of Tygacil, it showed a broad spectrum of antimicrobial activity.
Furthermore, it is difficult for bacteria to become resistant to Tygacil. One of the biggest problems with antibiotics is that, over time, bacteria often develop resistance to the most popular antibiotics. Drug-resistant infections (such as MRSA, MRSE, and VRE) that do not respond to the available antibiotics can easily progress, and can potentially spread to pandemic proportions.
Because Tygacil inhibits bacterial growth rather than selectively killing weak bacteria while leaving resistant bacteria alive, the chances that bacteria will become resistant to Tygacil is vastly decreased.
Tygacil Clinical Trial Results
The main finding of the clinical trials was that Tygacil is less effective than other antibiotics, except for drug-resistant bacterial infections and thus had an increased risk of mortality when it was used instead of other antibiotics. The conclusion was that Tygacil should only be used as a last-resort for complex, drug-resistant bacterial infections.
The study found:
- An increased risk of mortality observed in Phase 3 and 4 clinical trials, when Tygacil was used instead of other treatments.
- 4.0% (150/3788) of patients receiving Tygacil died, versus 3.0% (110/3646) of patients who were treated with other antibiotics.
- For patients with ventilator-associated pneumonia: Tygacil had much lower cure rates (47.9% versus 70.1% for the evaluated population).
- For patients with ventilator-associated pneumonia: Tygacil had higher mortality rates (19.1% versus 12.3% for the evaluated population)
- For patients who had infection-related serious adverse events: more common in those treated with Tygacil (7%) as opposed to patients who received other treatments (6%)
- For patients who developed sepsis/septic shock: more common with Tygacil (2%) versus other treatments (1%)
FDA and NCBI Tygacil Warning
FDA issued a safety announcement in September 2010, because the results of a new study found that patients who received Tygacil as opposed to other antibiotics were at an increased risk of death – though researchers do not know why Tygacil is less effective at curing bacterial infections, it is likely that Tygacil’s mechanism of inhibiting bacterial growth is simply less effective than killing the bacteria directly. For this reason, the FDA safety announcement directed physicians to use other antibiotics, except as a last resort when drug-resistant bacteria produced a complex infection.
The FDA also required that the drug’s manufacturers change the label to include the new information found in the study.
The FDA 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.”
The National Center for Biotechnology Information (NCBI) published a study by the Baylor University Medical Center in Dallas, TX, which was intended to be a guide for physicians researching the pharmacodynamics, spectrum of activity, efficacy, adverse effects of Tygacil. The conclusion of the researchers was clear:
”[Tygacil] should not be used for patients who are not at risk of resistant infections.”
It is important to note that the mortality rate for FDA-approved uses of Tygacil (such as serious skin infections and intra-abdominal infections) was not significant. Tygacil performed comparably to other available alternatives. The findings that prompted the FDA and NCBI to issue warnings was for conditions that are not approved uses, such as hospital-acquired pneumonia (including ventilator-associated pneumonia) and diabetic foot infection.
Other Serious Side Effects:
- anaphylaxis/anaphylactoid reactions
- acute pancreatitis
- hepatic cholestasis, and jaundice
- severe skin reactions, including Stevens-Johnson Syndrome
Tygacil Class Action Lawsuit Information
The Clark Firm, LLP is nationally recognized as a class action law firm, but we are not filing a Tygacil class action lawsuit. Instead, our attorneys are reviewing claims and filing individual lawsuits on behalf of people who were seriously injured or died after being treated with Tygacil.
Do I Have a Tygacil Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact our Texas Tygacil lawyers for a free lawsuit review.