Tygacil Side Effects Require Black Box Warnings, Petition to FDA Claims

The prominent consumer advocacy group Public Citizen is calling for the FDA to require a new black box warning for the antibiotic Tygacil, indicating that the drug carries a higher mortality rate when compared to other antibiotics. 

A petition for a Tygacil black box warning was filed with the FDA last week, suggesting that the strongest label warning possible should be added to Tygacil because current mortality risk information on the label is inadequate.

Public Citizen also wants the FDA to require that a medication guide be given to patients and that the agency send out a “Dear Doctor” letter clarifying the potential risk of Tygacil side effects for physicians.

The black box warning should alert users to the fact that there is an increased risk of death when using Tygacil, Public Citizen said in a letter (pdf) to FDA Commissioner Margaret A. Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock. The Tygacil black box warning should also indicate that the drug is an antibiotic of last-resort after other treatments have failed, and should only be used in combination with one or more antibacterial antibiotics, the group urged.

Tygacil (tigecycline) was approved by FDA for the treatment of certain types of infections in June 2005. Created by Wyeth, which is now owned by Pfizer, Inc., the drug is approved to treat complicated skin infections, intra-abdominal infections, and community-acquired pneumonia. It is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia).

In September 2010, the FDA issued a Tygacil safety alert after analyzing a number of clinical trials that indicated that the mortality rate with Tygacil was higher when treating all types of infections, but particularly when treating ventilator-associated pneumonia. Patients given Tygacil to treat pneumonia had a 20% chance of dying, compared to only 12% from competing antibiotics. The agency required new information on the mortality rate be added to the drug’s label, but Public Citizen officials called those label changes “woefully inadequate.”

Hospital-acquired pneumonia is a common risk for critically ill patients, particularly those on ventilators. Contraction of pneumonia puts critically ill patients at a 20 to 30 percent risk of death, and can increase a patient’s hospital stay by seven to nine days, potentially exposing them to other complications. Pneumonia usually occurs because stomach secretions have entered the lungs.