引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Canada: Summary Safety Review: Tramadol-containing products: Assessing the potential risk of hallucinations (English only) |
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Health Canada announces that it reviewed the risk of hallucinations with tramadol-containing products. The safety review was triggered by information submitted from a manufacturer showing an increase in the number of reported cases (Canadian and international reports) of hallucinations with tramadol use at normal doses.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, scientific and medical literature as well as information received from one of the manufacturers. At the time of the review, Health Canada had received 54 Canadian reports of hallucinations related to the use of tramadol-containing products. Of the 54 Canadian reports, only 2 met the criteria for further assessment to determine if there was a link between the use of tramadol and hallucinations. The remaining 52 reports could not be assessed due to several contributing factors such as incomplete information in the reports, or the patients were taking other medications at the same time that may have contributed to this risk.
Health Canada reviewed 24 serious case reports (2 Canadian and 22 international) of hallucinations with the use of tramadol-containing products. Of the 24 case reports, 1 case (an elderly patient) was found to be probably linked, 18 cases (including 2 Canadian cases) were possibly linked, with 11 of these 18 cases involving elderly patients, 1 case was not likely to be linked, and 4 cases did not have enough information to be assessed. Health Canada also assessed a review from the published scientific literature that included 101 cases of hallucinations with the use of tramadol. Most reported hallucinations were visual and/or auditory and occurred in patients older than 65 years of age. Health Canada's review of the published study supported a possible link between hallucinations and tramadol use.
Health Canada's review of the available information has established a link between the use of tramadol-containing products, at normal doses, and the risk of visual and auditory hallucinations, especially in patients over 65 years of age. Health Canada will work with manufacturers to update the Canadian product safety information for tramadol products to include the risk of visual and auditory hallucinations at normal doses, including a higher risk in patients over 65 years of age.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00253
In Hong Kong, there are 49 registered pharmaceutical products containing tramadol. All products are prescription-only medicines. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction related to tramadol, but these cases are not related to hallucinations. 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/Wednesday, Dec 30, 2020
Issued at HKT 15:00
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