Tygacil (tigecycline), an antibacterial manufactured by the drug maker Pfizer, increases the risk of death, whether used for approved uses or for purposes that are off-label, according to a warning just issued by the U.S. food and Drug Administration (FDA).
The agency said that Pfizer must now update Tygacil’s warning information to include the so-called “Black Box” label, the agency’s most serious warning indication. Tygacil, which is administered intravenously, should only be used when no other alternative treatments are available, the FDA stated, according to Reuters.
Tygacil received agency approval in 2004 for the treatment of complicated skin and abdominal infections and community-acquired bacterial pneumonia. Tygacil is not approved for the treatment of diabetic foot infection or for the treatment of hospital-acquired pneumonia, Reuters reported.
A physician reminder was issued by the FDA in September 2010. That reminder indicated that Tygacil carried an increased risk of death when compared to other medications prescribed for the treatment of infection, according to Reuters. At that time, the agency indicated that it has conducted a review of pooled clinical trial data and found that most of the deaths were related to infection progression, according to Reuters.
The FDA also indicated that the increased death risk was generally observed in patients diagnosed with hospital-acquired pneumonia; however, that risk was seen in patients who were diagnosed with other types of infection. At that time, the agency also updated the “Warnings and Precautions” section of the label to reflect the increased risks, Reuters wrote.
Since the 2010 notice, the FDA has reviewed data from 10 trials, it has stated. The trials included patients who had taken Tygacil for FDA-approved uses only. According to Reuters, the review revealed an increased risk of death even when taken for FDA approved uses when compared to other antibacterial medications. The Associated Press (AP) pointed out that this current review confirmed the prior analysis.
The deaths were associated with infections that either worsened or led to complications. Deaths were also blamed on other underlying medical conditions, according to the FDA. The greatest risks were seen in patients diagnosed with ventilator-assisted pneumonia, an unapproved Tygacil use, according to the AP.
According to the FDA, it is not clear why Tygacil is tied to increased death risks when compared to other drugs.