Public Citizen Petition for Black Box Warning on Tygacil Updated

Public Citizen, a prominent consumer watchdog organization, is reviving efforts to get more stringent warnings added to the antibiotic Tygacil, indicating the drug has an increased risk of death. 

The group petitioned the FDA last October to add a “black box” label warning to Tygacil, and updated that petition last month. The FDA has not yet made any decision on the original petition.

According to Public Citizen, Tygacil should have the strongest label warning possible to alert patients and doctors that the antibiotic has an increased risk of death when compared to other antibiotics and should only be used as a treatment of last resort to treat the most serious infections. Even then, Public Citizen suggests the drug be used with one or more bactericidal antibiotics.

Public Citizen is also asking the FDA to distribute a patient guide with data on the risk of death and restrictions on use. Pfizer, the manufacturer of the drug, should also be required to send a “Dear Doctor” letter to physicians explaining the drug’s dangers, according to the group.

The updated petition includes data from recently completed randomized clinical trials that show a 0.7% increased mortality rate among Tygacil users and a 2.9% increase in non-cure rates. The researchers in that study noted: “Clearly, tigecycline should not be used when other effective antibiotic choices are available.”

New data submitted by Public Citizen also claims that using Tygacil would result in one excess death for every 143 patients treated and one “noncure” for every 34 patients treated.

Tygacil (tigecycline) was approved by FDA for the treatment of certain types of infections in June 2005. Created by Wyeth, which is now a subsidiary of 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).

Last summer, the FDA issued a Tygacil safety alert noting 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 dtying, compared to only 12% from competing antibiotics.