Tygacil Label Updated to Reflect Increased Death

The U.S. Food and Drug Administration (FDA) has issued a reminder to healthcare professionals of an increased mortality risk associated with use of the intravenous antibacterial <"http://www.yourlawyer.com/practice_areas/defective_drugs">Tygacil (tigecycline), over 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 those patients with ventilator-associated pneumonia. The risk was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections, and diabetic foot infections. The FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.

Tygacil is FDA-approved 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. The Data Summary section can be accessed at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm

The FDA advised that alternatives to Tygacil should be considered in those 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.fda.gov/MedWatch/report.htm. 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.

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