其 他 安 全 警 示
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| The United States: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems: Update (English only) |
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The US Food and Drug Administration (FDA) announces an update to its previous Drug Safety Communication about hydroxychloroquine and chloroquine. Based on ongoing analysis and emerging scientific data, FDA has revoked the emergency use authorization (EUA) to use hydroxychloroquine and chloroquine to treat COVID-19 in certain hospitalized patients when a clinical trial is unavailable or participation is not feasible. FDA made this determination based on recent results from a large, randomized clinical trial in hospitalized patients that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery. This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19. As a result, FDA determined that the legal criteria for the EUA are no longer met.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or
In Hong Kong, there are 5 registered pharmaceutical products containing hydroxychloroquine, and all products are prescription-only medicines. There is no registered pharmaceutical product containing chloroquine. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to hydroxychloroquine, but these cases are not related to heart rhythm problems. The DH has not received any case of adverse drug reaction related to chloroquine.
Related news on the risk of heart rhythm problems associated with the use of hydroxychloroquine and chloroquine was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 24 Apr 2020, with the latest update posted on 3 Jun 2020. Adverse effects and precautions about heart rhythm problems associated with the use of hydroxychloroquine and chloroquine 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/Tuesday, Jun 16, 2020
Issued at HKT 16:00
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