The drug Tygacil (generic: tigecycline) has recently been linked to an increased risk of death by the FDA. Tygacil is a new type of broad-spectrum antibiotic approved to treat complicated intra-abdominal infections, skin infections, and community-acquired bacterial pneumonia. The greatest risk of death was seen in patients treated for ventilator-associated pneumonia, and diabetic foot disease, which are unapproved uses.
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 watchdog group Public Citizen is calling on the FDA to add a “Black Box” warning to the label of Tygacil, which would clearly warn that Tygacil is associated with a higher risk of death than other antibiotics. An update to the petition includes the results of a new scientific 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) is a prescription medicine created by Wyeth Pharmaceuticals, now owned by Pfizer Inc. It is the first drug in a new class of antibiotics called glycylcyclines, approved for use in the U.S. in 2005 to treat complex bacterial infections.
The FDA granted Tygacil priority review status because of its effectiveness against severe, drug-resistant infections. It is active against penicillin-resistant Streptococcus pneumoniae, methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis (MRSE), and vancomycin-resistant Enterococcus (VRE).
Unlike other antimicrobials that treat infection by directly killing the bacteria, Tygacil works by inhibiting bacterial growth. Tygacil prevents protein synthesis by halting the incorporation of amino acids into peptide chains. Because of the unique structure of Tygacil, it has a broad spectrum of antimicrobial activity, and decreased susceptibility to the development of resistance.
FDA Study & Safety Announcement
In September of 2010, the FDA issued a safety announcement to inform physicians of the results of a new study. The study found that there is an approximately 30% increase in the mortality rate for people receiving Tygacil as opposed to other antimicrobials.
The FDA recommended physicians use alternative treatments. They also required changes to the drug label to include information about the increased mortality risk.
The most significant increase in the mortality rate was for conditions not approved by the FDA. Hospital-acquired pneumonia (including ventilator-associated pneumonia) and diabetic foot infection are not approved uses of Tygacil, yet they have been treated with this drug.
“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.”
Though researchers do not know why Tygacil has a far lower cure rate than other antimicrobials when treating unapproved infections, it is possible that Tygacil’s mechanism for inhibiting bacteria growth is less effective than other antimicrobials that directly kill the bacteria.
National Center for Biotechnology Information Recommendation
Baylor University Medical Center in Dallas, TX published a general study of Tygacil, which included its pharmacodynamics, spectrum of activity, efficacy, adverse effects, and finally a recommendation for physicians who might use this antimicrobial on a patient. Their recommendation was clear:
”[Tygacil] should not be used for patients who are not at risk of resistant infections.”
Findings of the Clinical Trials of Tygacil
- An increase in all-cause mortality observed across Phase 3 and 4 clinical trials in Tygacil-treated patients versus other treatments.
- Death occurred in 4.0% (150/3788) of patients receiving Tygacil and 3.0% (110/3646) of patients receiving other treatments.
- The sub-group of patients with ventilator-associated pneumonia who received Tygacil had lower cure rates (47.9% versus 70.1% for the clinically evaluable population).
- Greater mortality was seen in patients with ventilator-associated pneumonia who received Tygacil (19.1% versus 12.3% in patients receiving other treatments).
- Infection-related serious adverse events were more frequently reported for subjects treated with Tygacil (7%) versus patients receiving other treatments (6%).
- Sepsis/septic shock were more frequently reported for subjects treated with Tygacil (2%) versus comparators (1%)
Other Serious Side Effects:
- anaphylaxis/anaphylactoid reactions
- acute pancreatitis
- hepatic cholestasic
- severe skin reactions, including Stevens-Johnson Syndrome
Tygacil Class Action Lawsuit
Our Defective Drug Litigation Group are nationally recognized as class action attorneys, but we are not filing a Tygacil class action lawsuit. Instead, we are reviewing claims and filing individual lawsuits on behalf of people who were seriously injured or died after being treated with Tygacil.