ADR that result in revision of patient information
|
| |
| Canada: Ezetrol (ezetimibe) and the risks of drug-induced liver injury and severe cutaneous adverse reactions |
| |
Health Canada announces that Ezetrol (ezetimibe) may cause drug-induced liver injury (DILI) and severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilic and systemic symptoms (DRESS).
The Market Authorization Holder conducted a review of international safety data and the scientific literature and identified 42 post-marketing cases of DILI in patients taking Ezetrol, including a Canadian case of liver injury associated with ezetimibe monotherapy. There was sufficient evidence to suggest a causal association between ezetimibe monotherapy and DILI. Therefore, the current recommendation to consider performing liver function tests at the initiation of, or during treatment with, Ezetrol in combination with a statin or fenofibrate has been expanded to include Ezetrol monotherapy.
The review also identified rare cases of SCARs in patients taking Ezetrol. There was sufficient evidence to suggest at least a reasonable possibility of a causal association with some cases of SJS, TEN, and DRESS.
Healthcare professionals are advised to:
- Consider performing liver function tests at the initiation of Ezetrol, whether administered as monotherapy or in combination with a statin or fenofibrate, and subsequently as required.
- Instruct patients to immediately contact a healthcare professional if they experience symptoms of liver injury. Liver function should be evaluated if liver injury is suspected.
- Instruct patients to stop taking Ezetrol and to seek immediate medical help if they experience symptoms of SCARs.
The Canadian Product Monograph (CPM) for Ezetrol has been updated to include warnings about these serious adverse reactions. Health Canada will work with the manufacturers of generic versions of ezetimibe to update their respective CPMs.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/ezetrol-ezetimibe-and-risks-drug-induced-liver-injury-and-severe-cutaneous-adverse
In Hong Kong, there are 21 registered pharmaceutical products containing ezetimibe. All products are prescription-only medicines. So far, with regard to ezetimibe, the Department of Health (DH) has received 6 cases of adverse drug reaction, of which one case was reported as acute hepatitis. All of the 6 cases were not related to SCARs. In light of the above Health Canada’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Mar 28, 2024
Issued at HKT 17:00
|
| |
|
