EMA: restriction for tigecycline
The Committee for Human Use (CHMP) of the EMEA has recommended in its meeting of February 2011, noted in the product of tigecycline for the increased mortality in clinical studies.
In the Product of tigecycline (Tygacil, Wyeth Europa Ltd.), a reference be made to that was elevated on administration of the antibiotic in clinical studies, the mortality rate, to ensure that the drug is used appropriately. Tigecycline should be used only in approved indications, especially complicated skin and skin structure infections and complicated intra-abdominal infections, and only when other antibiotics can not be applied.
Press release of 18 EMA February 2011
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