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Tygacil Linked to Increased Risk of Death: Black Box Warning

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September 27, 2013 — Tygacil (tigecycline), an injection antibiotic manufactured by Pfizer, has an increased risk of death compared to other antibiotics and will carry a “Black Box Warning.” The U.S. Food and Drug Administration (FDA) announced the change in a Drug Safety Communication.

The FDA found that 2.5% of Tygacil patients died, compared to 1.8% of patients on other antibiotics. These deaths generally resulted from worsening infections, complications, and underlying medical conditions. Their conclusions were based on data from over 5,000 patients in 10 clinical trials.

According to the FDA:

“The increased risk was greatest in patients treated with Tygacil for ventilator-associated pneumonia, a use for which FDA has not approved the drug. … Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.”

This is not the first time the FDA has warned about an increased risk of death from Tygacil. In September 2010, the FDA warned about an increased risk based on evidence from 7,000 patients in 13 clinical trials, in which 4% of Tygacil patients died, compared to 3% of patients on other antibiotics.

The year after this warning was published, the consumer advocacy group Public Citizen filed a petition calling for a “Black Box” warning on the label for Tygacil.

Tygacil (tigecycline) is an injection antibiotic that is administered in a hospital setting to treat severe infections. It was created by Pfizer and approved by the FDA in 2005. It is approved to treat complex skin and skin-structure infections, community-acquired pneumonia, and complicated abdominal infections. Tygacil is not approved to treat hospital-acquired pneumonia, ventilator-associated pneumonia, or diabetic foot infections. Click here to read the Tygacil Label Information.

 

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