ADR that result in revision of patient information
|
| |
| The United States: Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death |
| |
This update is in follow-up to the US Food and Drug Administration (FDA) Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections issued on September 1, 2010.
FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. A Boxed Warning is the strongest warning given to a drug. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010.
This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.
Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP). Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia.
Healthcare professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. Patients and their caregivers should talk with their healthcare professionals if they have any questions or concerns about Tygacil.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm370170.htm
In Hong Kong, there is one registered pharmaceutical product containing tigecycline, namely Tygacil for Injection 50mg (HK-54821). It is a prescription-only medicine. Related news had been released by FDA and EMA, and was posted on the Drug Office website on 2 September 2010 and 19 February 2011. Letters to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug were issued on 2 September 2010 and 21 February 2011. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee) in May 2011. The Committee decided that the package insert of Tygacil should include the relevant safety information. In view of the latest FDA announcement, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Committee.
Ends/ Saturday, September 28, 2013
Issued at HKT 12:00
|
| |
|
