引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
|
| |
| United States: Updated Tygacil drug label to include information regarding increased mortality risk (English Only) |
| |
FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. The FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil and it has also recommended that alternatives to Tygacil should be considered in patients with severe infections.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224626.htm
In Hong Kong: Tygacil is registered by Wyeth (HK) Ltd. The approved indications of Tygacil in Hong Kong include complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia. The company is in the process of updating the package insert of Tygacil to include a warning regarding the increased risk of mortality.
Ends/Thursday, September 2, 2010
Issued at HKT 15:00
|
| |
|
