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    Home > Chemial News > Policies > FDA and EMA Simultaneously warns of chloroquine

    FDA and EMA Simultaneously warns of chloroquine

    Echemi 2020-05-06

    About hydroxychloroquine and chloroquine

    Hydroxychloroquine and chloroquine are approved by the FDA to treat or prevent malaria. Hydroxychloroquine has also received FDA approval for the treatment of autoimmune diseases such as chronic discoid lupus erythematosus, adult systemic lupus erythematosus, and rheumatoid arthritis.


    Emergency authorized use is based only on limited evidence that these drugs may bring benefits, so the FDA authorizes the use of these drugs only in hospitalized patients after careful cardiac monitoring.


    FDA risk warning
    The FDA found that there are reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging drugs. The FDA is also aware of the increased use of these drugs through outpatient prescriptions. Therefore, the FDA wants to remind healthcare professionals and patients about the known risks associated with hydroxychloroquine and chloroquine. We will continue to investigate the risks associated with the use of hydroxychloroquine and chloroquine in COVID-19, and communicate openly as we obtain more information.


    Hydroxychloroquine and chloroquine have not been proven to be safe and effective for the treatment or prevention of COVID-19. They are conducting research in the clinical trial of COVID-19. If they do not participate in the clinical trial or are inconvenient to participate, we will use the emergency use authorization to temporarily use COVID-19 for the treatment of inpatients during the pandemic. The hydroxychloroquine / chloroquine authorized for emergency use is provided by the Strategic National Reserve, which is a national reserve of key medical supplies used in emergencies. When authorizing the use of hydroxychloroquine and chloroquine urgently, doctors and the public need to be reminded of the risk information listed in the instructions.


    Hydroxychloroquine and chloroquine can cause abnormal heart rhythms, such as prolonged QT interval and dangerous tachycardia called ventricular tachycardia. When these drugs are combined with other drugs known to prolong the QT interval (including the antibiotic azithromycin), these risks may increase. Without FDA approval, this drug can also be used in certain COVID-19 patients. Patients with other heart diseases (such as heart and kidney disease) may also be at increased risk for these heart diseases when receiving these drugs.

    EMA risk warning

    Previously, EMA stated that chloroquine and hydroxychloroquine are known to cause heart rhythm problems. If they are combined with other drugs that have similar effects on the heart (such as the antibiotic azithromycin), these problems may be exacerbated.

    Recent studies have reported that these cardiac rhythm adverse reactions of chloroquine or hydroxychloroquine are serious and even fatal in some cases, especially when used in high doses, or in combination with the antibiotic azithromycin.

    Chloroquine and hydroxychloroquine are currently approved for the treatment of malaria and certain autoimmune diseases. In addition to side effects that affect the heart, they can also cause liver and kidney problems, which can cause seizures (seizures) and damage to nerve cells with low blood sugar.

    The clinical data of chloroquine and hydroxychloroquine used in COVID-19 are still very limited and uncertain, and the beneficial effects of these drugs in COVID-19 have not been proven. The results from large, well-designed research are needed to support the conclusion.

    At present, in some clinical trials that study the effectiveness of chloroquine or hydroxychloroquine in the treatment of COVID-19, the dose used is higher than the recommended dose for indications. The recommended dose may have serious side effects, but higher doses may increase the risk of these side effects, including abnormal electrical activity that affects heart rhythm (prolonged QT).

    It is recommended that medical professionals closely monitor COVID-19 patients receiving chloroquine or hydroxychloroquine, and consider pre-existing heart problems that may make patients more prone to heart rhythm problems. They should carefully consider the possibility of side effects, especially at high doses, and when combined with other drugs that may cause similar side effects to the heart (such as azithromycin), be extra careful.

    Chinese Academy of Sciences: Candidate drugs have new discoveries

    On April 23, the reporter learned from the official website of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences that the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences issued a statement that the team of Liu Hong, Xu Yechun, Jiang Hualiang and Yang Haitao, Rao Zihe of the Shanghai University of Science and Technology and Zhang Lei, Wuhan Institute of Virology Li and Xiao Gengfu team made important progress in the study of anti-coronavirus drugs, and discovered a class of novel, highly efficient and safe antiviral drug candidates.

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