Safety advice on particular drugs or classes of drugs
|
| |
| Canada: Association of Samsca (tolvaptan) with a potential risk of liver damage |
| |
Otsuka Canada Pharmaceutical Inc. (Otsuka) in consultation with Health Canada informed healthcare professionals of important new safety information related to the potential risk of serious liver damage associated with the use of SAMSCA® (tolvaptan). Three (3) cases of liver damage were reported during clinical trials to study tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
SAMSCA is a drug currently approved to treat certain patients with clinically important, non-hypovolemic hyponatremia (low blood sodium levels). There was no liver damage reported in other clinical trials supporting the current approved use of SAMSCA. However, this is not sufficient to rule out the risk of liver damage for any patient taking SAMSCA. SAMSCA has the potential to cause irreversible and potentially fatal liver damage. Patients should immediately contact their doctor or pharmacist if they experience any of the following symptoms: fatigue, loss of appetite, right upper abdominal discomfort, dark urine, jaundice (yellowing of the skin or eyes).
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../23679a-eng.php
In Hong Kong, Samsca Tablet 15mg (HK-59910) and 30mg (HK-59911) are registered by Otsuka Pharmaceutical (HK) Ltd and are prescription-only medicines. So far, the Department of Health has not received any adverse drug reaction report in connection with
Samsca. News related to Samsca have been released by UK MHRA and US FDA and posted on the website of Drug Office on 31 March 2012 and 26 January 2013 respectively. A letter to inform healthcare professionals on the potential risk of liver injury was issued on 28 January 2013. This 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.
Ends/ Saturday, March 2 , 2013
Issued at HKT 12:00 |
| |
|
