ADR that result in revision of patient information
|
| |
| The United States: Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death |
| |
The Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death. Samsca is a selective vasopression V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca for a new use in patients with autosomal dominant polycystic kidney disease (ADPKD). FDA has worked with the manufacturer to revise the Samsca drug label to include these new limitations. The Samsca drug label has been updated to include the following information:
1. Limitation of the duration of Samsca treatment to 30 days.
2. Removal of the indication for use in patients with cirrhosis, a condition that involves scarring of the liver due to injury or long-term disease. Use of Samsca in patients with underlying liver disease, including cirrhosis, should be avoided because the ability to recover from liver injury may be impaired.
3. Description of liver injuries seen in clinical trials of patients with autosomal dominant polycystic kidney disease (ADPKD).
4. Recommendation to discontinue Samsca in patients with symptoms of liver injury.
Patients should be aware that Samsca may cause liver problems, including life-threatening liver failure, and should contact their healthcare professional to discuss any questions or concerns about Samsca.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm350185.htm
In Hong Kong, there are two registered pharmaceutical products containing tolvaptan, namely Samsca Tab 15mg (HK-59910) and Samsca Tab 30mg (HK-59911), and are prescription-only medicines. Safety alerts regarding the association of tolvaptan with potential risk of liver damage have been released by FDA and Health Canada, and were posted on the website of Drug Office on 26 January and 2 March 2013 respectively. A letter to inform healthcare professionals on the potential risk of liver injury was issued on 28 January 2013. The matter was discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board on 27 February 2013 and the Committee concluded that the Drug Office of the Department of Health to remain vigilant on any updated news of this medicine. In view of the latest FDA’s recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Committee.
Ends/ Thursday, May 02, 2013
Issued at HKT 18:00
|
| |
|
