The prominent consumer advocacy group Public Citizen, with a membership of over 225,000, 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 on October 26, 2011, suggesting that the strongest label warning possible should be added to Tygacil because current mortality risk information on the label is inadequate.
Public Citizen said in a letter to FDA Commissioner Margaret A. Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock, that “Tygacil has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and they believe it should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.”
The petition not only calls for the black box warning, but the distribution of an FDA-approved patient Medication Guide containing a warning about the above-mentioned increased risk of death and the need for restricted use, to be dispensed prior to the administration of the first dose of a course of tigecycline, as well as a requirement that the agency send out a “Dear Doctor” letter clarifying the potential risk of Tygacil side effects for physicians.
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).
But this isn’t the first the FDA has been warned of the problems associated with this medication. 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.
“Given 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,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “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. Such a warning, accompanied by stronger warnings describing appropriate restrictions on its use in other parts of the label, clearly is warranted to more effectively advise physicians about the dangers of using tigecycline to treat serious infections and to better protect public health.”
The petition did not give a requested timeline as to when this should take place, however, with the large membership and supporter base of this Advocacy group, one would hope that the FDA would take this petition seriously and consider placing these warnings as requested as soon as possible.