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: Sofosbuvir-containing products: Assessing the potential risk of severe cutaneous adverse reactions (English only) |
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Health Canada announces that it reviewed the potential risk of severe cutaneous adverse reactions (SCAR) in patients treated with sofosbuvir-containing products. The safety review was initiated when Health Canada became aware that the European Medicines Agency (EMA) updated the product safety information for all sofosbuvir-containing products with new information on the risk of Stevens-Johnson syndrome (SJS). The purpose of this review was to determine whether similar actions were required in Canada.
SCAR is a group of serious, potentially life-threatening, adverse reactions to drugs that involve the skin and inner lining of some organs. This safety review focused on specific types of SCAR: SJS and Toxic Epidermal Necrolysis (TEN) (a more severe form of SJS), Acute Generalized Exanthematous Pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Erythema Multiforme (EM) and Bullous Dermatitis (BD). While rare, SCAR can lead to hospitalization and death in some cases.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, published literature and information provided by the manufacturer. Health Canada reviewed 13 case reports (all foreign) of SCAR in patients receiving sofosbuvir-containing products. Of the 13 case reports, 6 reports involved SJS/TEN (4 SJS, 1 TEN and 1 unclear whether SJS or TEN), 5 reports involved EM, and 2 involved BD. Of the 6 SJS/TEN case reports, 1 case (SJS) was found to be probably linked to the use of sofosbuvir-containing products, 4 cases were possibly linked (2 SJS, 1 TEN, 1 TEN/SJS), and 1 case (SJS) was unlikely to be linked. Of the 5 EM case reports, 4 cases were found to be possibly linked to the use of sofosbuvir-containing products, and one report could not be assessed further due to limited information in the report, co-existing medical conditions, and other drugs the patient was taking at the same time. Assessing the risk of EM in these reports was challenging because hepatitis C is a possible cause of EM. The two cases of BD could not be assessed further due to several contributing factors such as incomplete information about pre-existing medical conditions, lack of detailed information in the reports, and co-existing infections that may have contributed to BD.
Health Canada's review of the available information concluded that there may be a link between the use of sofosbuvir-containing products and the risk of SJS, but did not confirm a link with the risk of other types of SCAR. Health Canada will work with the manufacturer to update the Canadian product safety information for all sofosbuvir-containing products to include the risk of SJS in the Post-Market Adverse Drug Reactions section.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00256
In Hong Kong, there are 4 registered pharmaceutical products containing sofosbuvir, namely Sovaldi Tablets 400mg (HK-63501), Harvoni Tablets (HK-63886), Epclusa Tablets 400mg/100mg (HK-65046) and Vosevi Tablets (HK-65775). All products are registered by Gilead Sciences Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 16 cases of adverse drug reaction related to sofosbuvir, but these cases are not related to Stevens-Johnson syndrome. 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, Jan 28, 2021
Issued at HKT 16:00
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