其 他 安 全 警 示
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| Canada: Summary Safety Review: Carboplatin-containing products: Assessing the potential risk of Posterior Reversible Encephalopathy Syndrome (English only) |
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Health Canada announces that it reviewed the potential risk of Posterior Reversible Encephalopathy Syndrome (PRES) with carboplatin-containing products following a safety labelling update for PRES and these products in New Zealand. PRES is a rare and serious brain condition, which can include headaches, seizures, visual problems, nausea and vomiting. This condition is also known as Reversible Posterior Leukoencephalopathy Syndrome.
Health Canada reviewed information from searches of the Canada Vigilance database and scientific and medical literature. At the time of the review, Health Canada had not received any Canadian reports of PRES related to carboplatin use. Health Canada's review focused on 19 international case reports of PRES with the use of carboplatin-containing products (16 of them published in the medical literature). Health Canada concluded that a link between carboplatin use and PRES was possible in all 19 case reports. In all 19 cases, other factors that are known to be associated with PRES were present, such as the patients' general poor health, and several chemotherapy drugs given to the patients at the same time.
Health Canada's review of the available information concluded that there may be a link between the use of carboplatin-containing products and the risk of PRES. Health Canada will work with manufacturers to update the Canadian product safety information for carboplatin-containing products to include the risk of PRES.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00252
In Hong Kong, there are 15 registered pharmaceutical products containing carboplatin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 122 cases of adverse drug reaction related to carboplatin, but these cases are not related to Posterior Reversible Encephalopathy Syndrome.
The risk of encephalopathy including reversible posterior leukoencephalopathy associated with the use of carboplatin is documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Dec 17, 2020
Issued at HKT 16:00
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