其 他 安 全 警 示
|
| |
| The United States: FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information (English Only) |
| |
The following annoucement is related to planned labeling changes that were described in the recent FDA Drug Safety Communication on Chantix (varenicline) issued on 6/16/2011. FDA has approved an updated drug label for Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking - those with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD). The updated label now also includes alternative directions for patients to select a quit smoking date, which states that patients should start taking Chantix 7 days before their quit date or alternatively, begin Chantix dosing and then quit smoking between Days 8 and 35 of treatment.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm264436.htm
In Hong Kong, varenicline is registered as Champix Tab 0.5mg and 1mg by Pfizer Corporation HK Ltd. and are prescription medicines. The news has been released by the US FDA, Health Canada and Macau Health Bureau and posted on the website of Pharmaceutical Service on 17 June 2011, 28 June 2011 and 8 July 2011. A letter to inform healthcare professionals was issued on 17 June 2011. Department of Health will keep vigilance against any new safety information related to the drug.
Ends/ Saturday, July 23, 2011
Issued at HKT 12:00
|
| |
|
