- Salix's NDA for crofelemer in HIV-associated diarrhea assigned priority review status
- Genentech's BLA for pertuzumab receives priority review status in previously untreated HER2-positive metastatic breast cancer indication
- FDA reviewers questions efficacy of NeurogesX's Qutenza pain patch in proposed new use
- Shire's Vyvanse approved for maintenance treatment in adults with ADHD
- FDA accepts Ziopharm's IND application for oral formulation of Zymafos
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA updates label for Pfizer's Tygacil to warn of increased mortality risk
Thursday, September 02 2010 | Comments
What's This?
The Food and Drug Administration updated information on the label of Pfizer Inc.'s Tygacil (tigecycline) to reflect an increased risk of mortality associated with use of the drug as compared with other antibiotics prescribed to treat serious infections.The regulatory agency made the decision based on a pooled analysis of data from 13 clinical trials. The analysis evaluated the overall mortality among patients treated with Tygacil versus those treated with comparator drugs. Of the 3,788 patients who received treatment with Tygacil, 150, or 4 percent, died. Of the 3,646 patients treated with a comparator antibiotic, 110 died, representing a lower mortality rate of 3 percent.
The increase in mortality risk associated with Tygacil treatment was most evident in patients with ventilator-associated pneumonia, an indication for which the agent is not approved, the FDA noted. The increased risk of death was also seen in patients with foot infections resulting from diabetes, which is also an unapproved use, as well as those with complicated skin and skin structure infections and complicated intra-abdominal infections, both of which are approved indications.
Tygacil is also approved for use in treating community-acquired pneumonia.
The FDA said health care professionals should consider alternatives to Tygacil when treating patients with severe infections.
Comments
Be the first to write a comment for this article!
You must be logged in to post a comment.
- White blood cell count in presence of elevated ESR, CRP level predicts infection status in patients undergoing total hip arthroplasty, researchers report
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
- Symptoms of early, delayed puberty demand close clinical attention, in spite of shifting norms for pubertal onset
- Low-dose doxepin improves wake after sleep onset among individuals with primary insomnia, data indicate
- School-based nutrition, exercise intervention program may not maintain BMI decreases through 10 months in overweight students, data indicate
- Careful discharge planning, follow-up vital for high-risk neonates facing hospital discharge, updated AAP guidelines state
- Nissen fundoplication in children with GERD reduces need for antireflux medication, researchers find
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
