其 他 安 全 警 示
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| European Union: Review of terlipressin medicines started (English only) |
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The European Medicines Agency (EMA) announces that it has started a review of medicines that contain terlipressin. These medicines are authorised in several EU countries to treat increased pressure in central veins causing kidney problems in people with advanced liver disease (hepatorenal syndrome; HRS), as well as bleeding from enlarged veins in the passage between the mouth and the stomach (the oesophagus) and certain forms of bleeding associated with surgery.
EMA’s safety committee (PRAC) started this review due to safety concerns about results from a large clinical trial involving patients with a form of HRS where kidney function declines rapidly. The results suggest that patients who were treated with terlipressin were more likely to experience and die from respiratory disorders within 90 days after the first dose than those who were given placebo (a dummy treatment). Respiratory disorders, such as respiratory failure (severe breathing difficulties), are a known risk of these medicines. However, the frequency of respiratory failure seen in this study (10%) was higher than reported in the product information, where it is listed as uncommon (i.e., affecting up to 1% of patients).
As a result of these concerns, the Danish medicines agency requested a review of the safety of terlipressin medicines in the context of their benefits when used to treat HRS. At present, this review does not cover the use of terlipressin for the treatment of bleeding, since no new information on safety concerns has emerged for these uses.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-january-2022
In Hong Kong, there are 4 registered pharmaceutical product containing terlipressin. All these products are prescription-only medicines. So far, the Department of Health (DH) has not received cases of adverse drug reaction related to terlipressin. In light of the above EMA’s announcement, the DH will remain vigilant on the conclusion of the review and any safety updates issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, January 15, 2022
Issued at HKT 12:30
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