Patients with complicated skin infections, community-acquired pneumonia, and intra-abdominal infections are often prescribed the antibiotic tigecycline. Most consumers will see it as Tygacil in their medicine cabinet. But new research is finding that some doctors, and most patients, are not aware of tigecycline’s high mortality rates as compared to other antibiotics that could be used to treat the same concerns. Dr. Michael Carome, the deputy director of the Health Research Group at Public Citizen, estimates that the medicine has a 30 percent higher mortality rate, but the FDA does not have a black box warning at the top of the medicine to warn physicians and patients.
“Because of the increased death rate and the likely inappropriate use of tigecycline as a first-line, rather than last-resort, antibiotic for serious infections without simultaneous administration of other antibiotics, it is inexcusable that there is currently no black box warning for tigecycline,” said Carome.
Alternatives to this antibiotic should be explored before a patient is given tigecycline. If it must be given, it should be taken with a combination of bactericidal antibiotics that kills bacteria and does not interfere with growth of bacteria. Because of the power of this drug, Public Citizen advocates that a FDA-approved guide be given to patients about this medicine. It also wants the FDA to send out a “Dear Doctor” letter to warn doctors of the complications and restricted use of the drug.
The FDA originally approved the Pfizer antibiotic back in 2005 for skin and intra-abdominal infections. In 2009, it was approved for community-acquired pneumonia. From 2008 through 2011, sales for Tygacil were an estimated $480 million and 82,000 prescriptions were filled in the U.S. The FDA did require an update to the Tygacil label in 2010, but it only contained stronger warnings. Black box warnings are more prominent, give more guidance, and alert the physician to seek other routes unless there is no clear alternative.
When a loved one has died and a family member discovers they were using Tygacil, it is important to speak with a wrongful death lawyer to see if they have a claim. If the doctor did not try alternatives or ignored warnings, he or she can be held liable for the death.
Paul Greenberg is a Chicago wrongful death attorney and Chicago wrongful death lawyer with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.
