European Medicines Agency's Q&A on the review of Tygacil (tigecycline)
Monday 14 March 2011
The European Medicines Agency has completed a review of the benefit-risk balance for Tygacil, as part of the procedure for the marketing authorisation renewal, five years after the medicine was first authorised. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Tygacil continue to outweigh its risks but recommended changes to the product information to ensure that it is used appropriately, by making prescribers aware that the medicine has been associated with an increased mortality in clinical studies.
In this context:
* Doctors are reminded that Tygacil is only indicated in the treatment of patients with complicated skin and soft tissue infections and complicated intra-abdominal infections.
* They should only use Tygacil when other antibiotics are not suitable.
* Patients on Tygacil should be monitored closely, especially to detect the possible development of superinfections. Superinfection, in particular pneumonia, can be associated with poor patient survival. If a superinfection occurs, treatment should be switched to another antibiotic.
* Patients who are or have been treated with Tygacil and have any questions should speak to their doctors to discuss their treatment.
The complete questions and answers document referring to this matter can be found in the following link:
>> http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500102228
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