Tygacil Gets Updated Warning Label from FDA
Tigecycline (Tygacil) has received an updated warning label from the Food and Drug Administration. The new label states that alternatives to Tygacil should be considered in treating serious infections due to Tygacil’s increased risk of mortaility in comparison with other antibiotics in treating infections.
The increased mortality risk was most prevalent in those being treated for hospital acquired pneumonia for which Tygacil is not FDA approved. Tygacil is FDA approved for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia.
According to an FDA safety alert, “alternatives to Tygacil should be considered in patients with severe infections.”
Doctors may prescribe drugs for so-called “off label” uses ie. uses not approved by the FDA. However, drug companies are not allowed to market their drug products for anything other than those uses approved by the FDA.
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