Tygacil FDA Alerts
The FDA Alert(s) below may be specifically about Tygacil or relate to a group or class of drugs which include Tygacil (tigecycline).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for tigecycline
Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death
Sep 27, 2013
Audience: Infectious Disease, Critical Care, Pharmacy
ISSUE: FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010.
This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.
BACKGROUND: Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).
RECOMMENDATION: Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.
[09/27/2013 - Drug Safety Communication - FDA]
Tygacil (tigecycline): Label Change - Increased Mortality Risk
Sep 1, 2010
Audience: Infectious Disease, Critical Care Medicine, Internal Medicine
ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.
BACKGROUND: Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. The increased risk was determined using a pooled analysis of clinical trials. See the Data Summary section of the FDA Drug Safety Communication for additional details.
RECOMMENDATION: Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/01/2010 - Drug Safety Communication - FDA]
