Healthcare

Tigecycline is antibiotic that approved by U.S. Food and Drug Administration used for complicated intra-abdominal infections and complicated skin and skin-structure infections, as well as for community-acquired pneumonia.
However, this antibiotic not approved for diabetic foot infections or hospital-acquired pneumonia.

Recent alert in September 1, 2010 from FDA, the agent suggest clinicians should consider alternative intravenous antibiotics due to this antibiotic (marketed as Tygacil from Wyeth Pharmaceutical) is linked to an increased risk for death in patients with certain severe infection.

In the statement from agency, the increased mortality risk is most apparent in patients treated for hospital-acquired pneumonia, particularly ventilator-associated pneumonia.
Also, the agency discerned the increased risk in patients with complicated intra-abdominal infections, diabetic foot infections, and complicated skin and skin-structure infections.

Based on 13 trial pooled analysis, patients who received tigecycline both approved and unapproved indications, they found that compared 3% of death occurred in patients who received other antibiotics, death patients who received tigecycline was 4%.

The agency stated, “The cause of the excess deaths in these trials is often uncertain, but it is likely that most deaths in patients with these severe infections were related to progression of the infection.”

The FDA noted that tigecycline is generally considered to be a bacteriostatic drug; that is, it inhibits the growth of bacteria as opposed to killing them outright. However, it has demonstrated bacterial activity against isolates of Streptococcus pneumonia and Legionella pneumophilla.
The agency said, “One possible reason for the mortality difference is that in certain severe infection, Tygacil’s bacteriostatic mechanism may put it at some disadvantage, although for approved indications, cure rates with Tygacil were generally similar to that seen with the bactericidal active control agents.”

To report adverse events related to tigecycline, contact the FDA’s safety information and adverse event reporting program, MedWatch;
- at 1-800-FDA-1088 (by telephone0,
- at 1-800-FDA-0178 (by fax),
- at online http://www.fda.gov/medwatch , or
- mail to MedWatch, FDA, 5600 Fisher Lane, Rockville, Maryland 20852-9787.