其 他 安 全 警 示
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| Health Canada: Summary Safety Review - Tamiflu (oseltamivir) and generics (English only) |
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Health Canada announces that it reviewed the potential risk of bleeding (haemorrhages) in general with the use of oseltamivir to determine whether additional actions were required in Canada. The safety review was started when Health Canada became aware that the Japanese Pharmaceutical and Medical Devices Agency (PMDA) updated the product safety information for oseltamivir with new information on the risk of haemorrhages in general.
In Canada, oseltamivir is a prescription drug authorized for sale in Canada to treat or prevent the onset of flu.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, and published literature. Health Canada reviewed 59 case reports (4 Canadian, 55 international) of bleeding in patients receiving oseltamivir. Of the 59 case reports, 42 reports showed a possible link between oseltamivir use and haemorrhages, with 22 of these involving bleeding in the lower gut (gastrointestinal bleeding). Three cases were unlikely to be linked to oseltamivir use, and 14 cases (4 Canadian) could not be assessed 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 the adverse event.
Health Canada also reviewed 5 articles published in the scientific literature on the risk of bleeding and oseltamivir use. There was limited information to support a link between the potential risk of bleeding and the use of oseltamivir in 4 of the 5 articles. In addition, Health Canada reviewed 4 articles from the published scientific literature for a potential interaction between oseltamivir and warfarin, a blood thinner medication that may cause bleeding. Overall, the review did not find evidence to support an interaction between oseltamivir and warfarin leading to increased bleeding. The information reviewed was inconclusive regarding the risk of bleeding in general. However, the review concluded that there may be a link between the use of oseltamivir and the risk of lower gastrointestinal bleeding. The Canadian product safety information for oseltamivir already includes information on the risk of gastrointestinal bleeding.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00255
In Hong Kong, there are 17 registered pharmaceutical products containing oseltamivir. All products are prescription-only medicines. So far, the Department of Health (DH) has received 18 cases of adverse drug reaction related to oseltamivir; but none of them is related to bleeding. The risks of haemorrhage, including gastrointestinal bleeding, are documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Saturday, Jan 09, 2021
Issued at HKT 14:30
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