Rx Drug Tygacil Label Change due to Elevated Risk of Mortality
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A new label change for the antibiotic rx drug Tygacil was FDA-ordered, due to increased risk of mortality when compared to other antibiotic drugs. The recent decision came after an analysis of 13 clinical studies which showed that patients who were administered with the drug to treat pneumonia had a 20% risk of dying, versus only 12% of patients on alternative antibiotics.
When treating ailments other than pneumonia, patients who were prescribed Tygacil faced a 4% higher risk of death, compared to a 3% risk with other antibiotics. However, the difference may not be clinically significant, since treated patients are often seriously ill or near death. The FDA has, nonetheless, decided to update the drug’s label. While the mortality increase was clearly noted in phase III and IV clinical trials, the precise cause of this overall increase has not yet been established.
Tygacil - RX Drug Information
The prescription drug is manufactured by Pfitzer, and was approved by the FDA in 2005 to treat complex skin infections, diabetic foot infections, intra-abdominal infections and community acquired bacterial pneumonias. The prescription antibiotic is not used to treat hospital acquired pneumonia.
The updated label will include information about increased mortality risks associated with Tygacil. The FDA has also recommended that physicians consider alternative antibiotic therapy before prescribing Tygacil.
The FDA requests that physicians and patients report any adverse reactions or side effects associated with this rx drug to the FDA’s MedWatch Safety Information and Adverse Reporting Program.
