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: Pomalyst (pomalidomide) and Thalomid (thalidomide): Assessing the potential risk of progressive multifocal leukoencephalopathy (English only) |
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Health Canada announces that it reviewed the potential risk of a rare brain infection known as progressive multifocal leukoencephalopathy (PML) with the use of Pomalyst or Thalomid following reported cases of PML in patients taking Pomalyst. PML is an opportunistic infection in the brain caused by the John Cunningham (JC) virus. It is most frequently associated with a weakened immune system. PML is often fatal; therefore, it is important to detect it early so it can be appropriately managed.
Health Canada reviewed the available information from searches of the Canada Vigilance database, the World Health Organization's Adverse Drug Reaction Database, published literature and information provided by the manufacturer. At the time of the review, Health Canada had not received any Canadian reports of PML related to Pomalyst or Thalomid use. The safety review assessed 25 international case reports of PML in patients treated with pomalidomide (16 cases) or thalidomide (9 cases). For pomalidomide, 15 cases showed a possible link between this medication and PML, and 1 case did not have enough information to be further assessed. For thalidomide, 6 cases showed a possible link, while 3 cases were unlikely to be linked. All cases had other contributing factors, such as other medications taken by the patients that could have been possible causes of PML, or medical conditions that could have affected the patients' immune system and/or infection risk. Multiple myeloma itself is a risk factor for PML. Health Canada's review of the scientific literature did not find a clear mechanism to explain how Pomalyst or Thalomid could lead to PML.
Health Canada's review of the available information concluded that there is a possible link between Pomalyst or Thalomid and the risk of PML. The Canadian product safety information for Pomalyst has been updated to include a warning for the risk of PML. Health Canada is working with the manufacturer to update the Thalomid Canadian product information to include this rare safety issue.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00268
In Hong Kong, there are 4 registered pharmaceutical products containing pomalidomide, namely Pomalyst Capsules 2mg (HK-64089), Pomalyst Capsules 3mg (HK-64090), Pomalyst Capsules 1mg (HK-64091) and Pomalyst Capsules 4mg (HK-64092). All products are registered by Celgene Limited, and are prescription-only medicines. There is no registered pharmaceutical product containing thalidomide. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to pomalidomide, but these cases are not related to PML. 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/Friday, May 28, 2021
Issued at HKT 16:00
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