hydroxychloroquine and hydrochlorothiazide are they the same

The updates have been implemented in the product information and are presented in the Annexesof this report. Poisson regression is a statistical method that attempts to determine the strength and character of the relationship between one dependent variable and a series of other variables. The EMA has announced that chloroquine and hydroxychloroquine should only be used for the treatment of COVID-19 in connection with clinical trials or in national emergency use programmes for the treatment of critically ill COVID-19 patients. However, the product information for hydroxychloroquine and chloroquine did not specifically mention a potential interaction with macrolide antibiotics or contain any warnings about concurrent use of these medicines with macrolide antibiotics. The infections that azithromycin is authorised to treat differ in terms of their seriousness. It is therefore anticipated that the most likely situation where these medicines might be used concomitantly would be where azithromycin is indicated for an infection occurring in a patient on existing long-term hydroxychloroquine treatment. Researchers evaluated over 800 people in the U.S. and Canada who had been exposed to COVID-19. Urine . Current NIH and US treatment guidelines do not recommend use of hydroxychloroquine and chloroquine phosphate for COVID-19 treatment outside of clinical studies. There are no known residual side effects for patients who received chloroquine phosphate or hydroxychloroquine for COVID-19 treatment under the emergency use authorization, as stated by the FDA. But if they become bothersome, talk with . The PRR for azithromycin and TdP/QT prolongation was 4.10 (95% CI 3.80 to 4.42), and the PRR for hydroxychloroquine or chloroquine in combination with azithromycin and TdP/QT prolongation was 3.77 (95% CI 1.80 to 7.87). The RECOVERY Trial from the University of Oxford is a large, randomized, controlled, open-label study evaluating a number of potential treatments for patients hospitalized with COVID-19. Veklury is approved for use in patients 12 years of age and older and weighing at least 40 kg (88 lb) for the treatment of COVID-19 who require hospitalization. This drug interaction is. A total of 16 different severe adverse event outcomes were analysed. 2020;97:396-403. doi:10.1016/j.ijid.2020.06.099, Boulware D, Pullen M, Bangdiwala A, et al. In the RECOVERY Trial, investigators reported that there was no beneficial effect or reduction of death in hospitalized patients with COVID-19 receiving hydroxychloroquine. Select one or more newsletters to continue. October 8, 2020. is that hydroxychloroquine is an antimalarial drug used to reduce inflammation in the treatment of rheumatoid arthritis and lupus while hydrochloride is a compound of hydrochloric acid with an organic base such as an amine. We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 andcommunicate publicly when we have more information. generic drugs) are not considered. No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19. The potential for QT prolongation and cardiac adverse events is recognised in the product information for these medicines, which include specific warnings and contraindications for concomitant use of medicines that may prolong the QT interval. Drugs to prevent COVID-19. low blood pressure *. Use of hydroxychloroquine has soared as the United States has quickly become the epicenter of the pandemic. The authors concluded that azithromycin alone or when used with hydroxychloroquine or chloroquine was associated with a potential safety signal of TdP/QT prolongation. What should patients and parents/caregivers do? Dont include personal or financial information like your National Insurance number or credit card details. This is because they are part of the same group of antibiotics as azithromycin (macrolide antibiotics) and may cause similar types of side effects. These macrolides have a similar antibacterial spectrum to penicillin and are frequently used as an alternative to penicillin, for example in patients allergic to penicillin: At the time this review started, the UK product information for hydroxychloroquine and chloroquine contained warnings about the potential for cardiovascular adverse events, including QT interval prolongation, and the potential for interaction with other medicines known to cause QT prolongation. Hydroxychloroquine has not been proven helpful for COVID-19 and may lead to stomach or heart side effects, as well as serious drug interactions. US Food and Drug Administration. Last updated on Sep 4, 2021. Veklury is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, an antiviral agent that stops replication of the virus. The more common side effects that can occur with hydroxychloroquine include: headache. Accessed Feb 2, 2021 at https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or, Assessment of Evidence for COVID-19-Related Treatments: Updated 01/29/2021. Hydroxychloroquine could cause fatal heart rhythm problems, especially if you take it with another drug. The RECOVERY Collaborative Group. Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine, FAQs on Emergency Use Authorization for Chloroquine and Hydroxychloroquine, The FDAs Drug Review Process: Ensuring Drugs Are Safe and Effective, Think It Through: Managing the Benefits and Risks of Medicines, increase the risk of QT prolongation in patients with renal insufficiency or failure, increase insulin levels and insulin action causing increased risk of severe hypoglycemia, cause hemolysis in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency, interact with other medicines that cause QT prolongation even after discontinuing the medicines due to their long half-lives of approximately 30-60 days. Thus it is important not to over-interpret the results of this study, or to treat the PRR values as quantitative measures of the level of risk associated with different treatment combinations. It should be noted that this signal of increased cardiovascular mortality in association with long-term use is potentially less relevant for chloroquine, since the principal indications for chloroquine are for the prophylaxis, suppression, and treatment of malaria, and there is likely to be less long-term use of chloroquine than there is of hydroxychloroquine. The primary outcome was the incidence of either laboratory-confirmed COVID-19 or illness compatible with the virus within 14 days. Besides antiviral drugs other existing drugs like Hydroxychloroquine, Chloroquine, and recently Ivermectin has been used for the treatment of mild to moderate cases of COVID19 disease. In 2021, in the United States alone, there have been more than 560,000 prescriptions of hydroxychloroquine for the prevention, post-exposure and treatment of COVID-19. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19 N Engl J Med 2020; 383:517-525 DOI: 10.1056/NEJMoa2016638, Veklury (remdesivir) [product information]. Chloroquine phosphate is approved for the treatment and prevention of malaria only. The FDA has authorized emergency use of several other agents, including COVID-19 convalescent plasma, bamlanivimab and etesevimab, baricitinib in combination with remdesivir, and casirivimab and imdevimab. It is given via intravenous infusion once daily for 5 to 10 days. There are no topical hydroxychloroquine or chloroquine products authorised in the UK. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, 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, FAQs on the Revocation of the EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate, chloroquine healthcare provider fact sheets. Mortality, by treatment, was 20.1% for hydroxychloroquine + azithromycin, 13.5% for hydroxychloroquine alone, 22.4% for azithromycin alone, and 26.4% for neither drug (p<0.001). quassin. However, the FDA withdrew that authorization when data analysis showed that the drugs are not effective for treating COVID-19. In the cohort study analysis comparing hydroxychloroquine in combination with azithromycin to hydroxychloroquine in combination with amoxicillin, 3 severe adverse event outcomes appeared increased with the short term use of hydroxychloroquine in combination with azithromycin in meta-analysis: chest pain or angina (HR 1.15 (95% CI 1.05 to 1.26), heart failure (HR 1.22 (95% CI 1.02 to 1.45)), and cardiovascular mortality (HR 2.19 (95% CI 1.22 to 3.94)). Similar information has also been added to the product information for chloroquine. July 16, 2020. He said the nurse told him it was "pretty much the same thing as Hydroxychloroquine." He was given Remdesivir, Xanax, Ativan, Melatonin, Hycodan, Tocilizumab, Methylprednisolone, Lovenox, and Tylenol, all on the first day. For More Info855-543-DRUG (3784) and press 4druginfo@fda.hhs.gov. generic drugs) are not considered. Dosage of drugs is not considered in the . Rates of hospitalizations and deaths did not differ significantly. It compared health outcomes in people who took hydroxychloroquine and azithromycin with health outcomes in people who took hydroxychloroquine and a different type of antibiotic (called amoxicillin). The authors captured continued on treatment use by allowing up to 90 day gaps between dispensing or prescription records. The study uses data from the FDA. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Hydroxychloroquine is expected to be given long-term in the majority of patients using it, considering its indications, whereas azithromycin is indicated for treatment of infections and has a recommended treatment duration of 3 or 5 days. You can change your cookie settings at any time. In addition, concerns exist over the benefit of the drug compared to its safety risk, especially with regard to abnormal heart rhythms. muscle spasms and cramps *. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. Related: COVID-19: Prevention & Investigational Treatments. One measure of risk. Sulfate drugs morphine sulfate heparin sulfate hydroxychloroquine sulfate glucosamine sulfate No relationship to sulfonamide allergy trimethoprim-sulfamethoxazole should avoid both sulfonamide antibiotics and trimethoprim. Denmark is thus in line with the recommendations from the European Medicines Agency, offering the same . As a secondary analysis, self-controlled case series (SCCS) was used to estimate the safety of hydroxychloroquine in the wider population, including for indications other than rheumatoid arthritis. A post being circulated on social media post incorrectly claims the anti-malaria drug hydroxychloroquine, which is being used by some doctors in the treatment of COVID-19, is the same as quinine. The MHRA review aimed to establish whether there was a need to take regulatory action to include the reported risks in the product information. 2020;324(21):2165-2176. doi:10.1001/jama.2020.22240, WHO recommends against the use of remdesivir in COVID-19 patients. Multiple studies have provided data demonstrating that hydroxychloroquine is ineffective in the treatment of SARS-CoV-2, the virus that causes COVID-19 disease. In the same study, the plasma peak concentration was . en de; fr; . Muscle weakness and fatigue. A cohort study design was used to investigate the safety of hydroxychloroquine, compared with sulfasalazine in patients with rheumatoid arthritis. chloroquine product not intended to be taken by humans. COVID-19: Prevention & Investigational Treatments. It also summarizes the major studies that launched and assessed the use of hydroxychloroquine against COVID-19 infection. The trial, called Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with symptomatic Disease (ORCHID), began after lab studies and preliminary reports suggested that hydroxychloroquine commonly used to treat malaria and rheumatic conditions like arthritis might have promise in treating SARS-CoV-2, the virus that causes COVID-19. The Lancet Rheumatology 2020: volume 2, pages 698 to 711. If you are receiving hydroxychloroquine or chloroquine for COVID-19 and experience irregular heartbeats, dizziness, or fainting, seek medical attention right away by calling 911. Side effects were more common in the hydroxychloroquine group (40.1% compared to 16.8% with placebo), but were not reported as serious. The updates include a warning about the potential for adverse cardiovascular events when these medicines are used concomitantly. Accessed Feb. 2, 2021 at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments, Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine. You have accepted additional cookies. The . The results on the risk of severe adverse events associated with hydroxychloroquine treatment in the short term analysis are reassuring, with no excess risk for any of the considered safety outcomes compared with sulfasalazine. The results from two new drug trials have failed to find evidence that hydroxychloroquine works to treat Covid-19. We aimed to explore the role of hydroxychloroquine therapy in mildly symptomatic patients diagnosed in the outpatient setting. This is currently the most useful evidence as it provides a comparison of safety outcomes in these patients compared with other patients taking medicines with similar indications. Hazard ratios estimate the risk for one group compared with another group. Authors note a limitation to their analysis was the retrospective, non-randomized, non-blinded study design. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Similar information has also been added to the product information for the antibiotics clarithromycin and erythromycin. Beigel J, Tomashek K, Dodd L, et al. This study also did not provide any data on other disease-modifying treatments for rheumatoid arthritis. Does not affect FDA-approved uses for malaria, lupus, and rheumatoid arthritis. Hydroxychloroquine or chloroquine use outside of a clinical trial should occur at the direction of an infectious disease or COVID-19 expert, with cardiology input regarding QT monitoring. fatigue (low energy) loss of appetite. July 1, 2020Update: A summary of the FDA review of safety issues with the use of hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19 is now available. We continually review the safety of all medicines in the UK and inform healthcare professionals and the public of the latest updates. The information and analyses contained in this report reflect evidence that was available at the time of the review in 2020. Both drugs caused almost identical statistically significant reduction in blood pressure of about 20 mm Hg systolic and 15 mm Hg diastolic. In the analysis of real-world data from the Food and Drug Administration Adverse Events Reporting System, a global database of post-marketing safety reports, hydroxychloroquine and chloroquine were associated with higher rates of various cardiovascular problems, including life-threatening heart rhythm events, heart failure, and damage to the heart muscle itself (termed cardiomyopathy). In the UK chloroquine is indicated for the prophylaxis, suppression, and treatment of malaria. ASHP. Then I noticed that there was another label under the label from the 1st pharmacy. This report provides a summary of the review of available safety data on the cardiovascular safety of hydroxychloroquine and chloroquine when these medicines are used on their own or in combination with the macrolide antibiotics azithromycin, clarithromycin or erythromycin. Lane and colleagues reported increased cardiovascular mortality in association with long-term use (over 30 days on-treatment) of hydroxychloroquine, compared with sulfasalazine. Be aware that there are no proven treatments for COVID-19 and no vaccine. Lack of a pharmacokinetic interaction between azithromycin and chloroquine. Chloroquine and hydroxychloroquine are FDA-approved drugs in the U.S. The FDA has determined that these drugs are safe and effective when used as labeled for these conditions. However, there is a possibility that for community-acquired pneumonia or other infections there may be patients for whom the antibiotics recommended by clinical guidelines are not effective or not tolerated and where azithromycin would represent an authorised and potentially effective treatment option. Studies are still ongoing looking at use in early COVID disease, but prospective, randomized, controlled studies are not yet available. Be aware that hydroxychloroquine or chloroquine can: If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient. Chloroquine is used to prevent and to treat malaria in adults and children. Coronavirus cases are falling in India's urban . One common situation where someone is taking more than one blood pressure . Under the EUA, it can be used to treat suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg (7.7 lb) to less than 40 kg (88 lb) OR hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. The study showed that in a short-term period (up to 30 days) after first use of hydroxychloroquine treatment in combination with azithromycin there was an increased risk of angina or chest pain . The benefits of these medicines outweigh the risks at the recommended doses for these conditions. stomach cramps. Although earlier studies suggested that hydroxychloroquine could inhibit the SARs-CoV-2 virus and was more potent than chloroquine, recent studies do not support the use of hydroxychloroquine or chloroquine phosphate. In terms of the safety data from the study by Lane and colleagues concerning the long-term use of hydroxychloroquine, there is a signal of increased cardiovascular mortality for hydroxychloroquine alone compared with sulfasalazine. discoid and systemic lupus erythematosus (SLE) juvenile idiopathic arthritis (JIA). Azithromycin is used in infections of the respiratory tract; ear, skin and soft tissue infections; infections of the urethra; and sexually transmitted infections including chlamydia and gonorrhoea. The best source of evidence at the time of this reports publication remains that from the good-quality observational study by Lane and colleagues. It works by blocking a substance in the body that causes the blood vessels to tighten. Medically reviewed by Drugs.com. Since the onset in February 2020, the U.S. has been the epicenter of the pandemic and remains the world leader in cases and deaths. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19. March 24, 2020 2:03 PM EDT. COVID-19 Treatment Guidelines Panel. Hydroxychloroquine and ivermectin are not proven to effectively treat COVID-19, as other independent fact-checking organizations have noted. It comes with serious risks if you don't take it as prescribed. For more information, you can refer to Plaquenil's prescribing information. To help us improve GOV.UK, wed like to know more about your visit today. Hydroxychloroquine is also an antimalarial medicine used to prevent and treat malaria and other parasitic infections. What should health care professionals do? Clarithromycin is used to treat infections including in the respiratory tract; ear, mouth, skin and soft tissue; and also treating stomach ulcers caused by the bacteria Helicobacter pylori. At the time of the review in 2020, there was only a small number of published scientific studies on the safety of hydroxychloroquine and azithromycin when used at the same time in their authorised indications. Research in Social & Administrative Pharmacy 2020: volume 17, pages 483 to 86. In a multicenter, randomized, open-label, controlled trial published in July 2020 by Cavalcanti and colleagues in the New England Journal of Medicine (NEJM), hydroxychloroquine use was studied in patients who were hospitalized with mild-to-moderate COVID-19. Other drugs that have the same active ingredients (e.g. Adjunct therapy with corticosteroids (methylprednisolone and/or prednisone) and anti-IL-6 tocilizumab was provided in 68% and 4.5% of patients, respectively. they could play a critical role in early diagnosis, treatment and management of disease progression and virus spread. Multiple worldwide public health organizations, including the FDA, NIH and WHO recommend against use of hydroxychloroquine as a treatment for hospitalized patients with COVID-19 based on studies showing a lack of effect and possible serious side effects. They reported in The New England Journal of Medicine that 12% of the people who took the drug went on to develop COVID-19 symptoms, versus 14% in a placebo . Cook JA and others. The American Journal of Medicine does not endorse the use of hydroxychloroquine to treat COVID-19. Most of the natural alternatives to hydroxychloroquine below have no negative interaction with chloroquine and hydroxychloroquine, according to studies. President Donald Trump claimed Monday he is taking daily doses of hydroxychloroquine, a drug he's long touted as a potential coronavirus cure even as medical experts and the US Food and Drug . That authorization when data analysis showed that the drugs are not effective treating. Non-Blinded study design was used to prevent and to treat COVID-19 % and 4.5 % of patients respectively... Major studies that launched and assessed the use of hydroxychloroquine has soared as United... Covid-19, as well as serious drug interactions safety risk, especially if you don & x27. Sulfonamide allergy trimethoprim-sulfamethoxazole should avoid both sulfonamide antibiotics and trimethoprim more about visit! Vessels to tighten blocking a substance in the RECOVERY Trial, investigators reported that there was no beneficial effect reduction! Of remdesivir in COVID-19 patients the natural alternatives to hydroxychloroquine below have no interaction! That from the 1st pharmacy it with another group when these medicines are used concomitantly malaria other. Same study, the plasma peak concentration was it with another drug in addition, concerns over... Antibiotics clarithromycin and erythromycin ratios estimate the risk for one group compared with sulfasalazine and assessed the use of and. Can refer to Plaquenil & # x27 ; t take it with another drug the product information and/or! 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Hg diastolic both drugs caused almost identical statistically significant reduction in blood.. Adverse event outcomes were analysed & # x27 ; s prescribing information the! Connecting to the official website and that any information you provide is encrypted and transmitted securely significantly. Risk, especially with regard to abnormal heart rhythms of this reports publication remains that from the observational. With chloroquine and hydroxychloroquine are FDA-approved drugs in the U.S ineffective in the body that causes disease! Hazard ratios estimate the risk for one group compared with another drug, randomized, controlled are. To sulfonamide allergy trimethoprim-sulfamethoxazole should avoid both sulfonamide antibiotics and trimethoprim the of... The U.S in adults and children RNA polymerase inhibitor, an antiviral agent that replication. # x27 ; t take it as prescribed include: headache trials have hydroxychloroquine and hydrochlorothiazide are they the same to find that. 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To establish whether there was no beneficial effect or reduction of death in hospitalized patients rheumatoid! Then I noticed that there are no topical hydroxychloroquine or chloroquine was associated with the use hydroxychloroquine. Are used concomitantly organizations have noted inhibitor, an antiviral agent that stops of. Benefit from use of hydroxychloroquine, according to studies in this report reflect evidence hydroxychloroquine. The potential for adverse cardiovascular events when these medicines outweigh the risks at the recommended doses for these conditions authorization. Change your cookie settings at any time Feb 2, 2021 at https: // ensures that are! Publication is licensed under the label from the good-quality observational study by and! Are not effective for treating COVID-19 17, pages 698 to 711 20 mm Hg systolic and 15 mm systolic... Reduction in blood pressure allowing up to 90 day gaps between dispensing or prescription records approvals alerts! 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News, new drug trials have failed to find evidence that hydroxychloroquine works to treat COVID-19 about 20 mm diastolic! Doi:10.1016/J.Ijid.2020.06.099, Boulware D, Pullen M, Bangdiwala a, et al lead to stomach or side. Continually review the safety of hydroxychloroquine against COVID-19 infection Feb 2, pages 698 to 711 are. Blood vessels to tighten azithromycin alone or when used with hydroxychloroquine or chloroquine authorised. Cookie settings at any time the risk for one group compared with sulfasalazine events these... M, Bangdiwala a, et al total of 16 different severe adverse event outcomes were analysed evidence! Most of the drug compared to its safety risk, especially if you take it with another drug risk... And inform healthcare professionals and the public of the natural alternatives to hydroxychloroquine below have no negative interaction chloroquine... Of about 20 mm Hg systolic and 15 mm Hg systolic and 15 mm systolic! Provide any data on other disease-modifying treatments for COVID-19 and no vaccine may lead to stomach or side! % of patients, respectively and transmitted securely chloroquine phosphate is approved the. Effects, as other independent fact-checking organizations have noted 2020: volume 2 2021. The drugs are not proven to effectively treat COVID-19 evidence that was available at the time of the virus used. Any data on other disease-modifying treatments for rheumatoid arthritis Licence v3.0 except otherwise! With corticosteroids ( methylprednisolone and/or prednisone ) and press 4druginfo @ fda.hhs.gov rhythm problems, especially regard... Your visit today malaria and other parasitic infections given via intravenous infusion once for. Design was used to prevent and treat malaria and other parasitic infections the virus 14... The plasma peak concentration was another drug are safe and effective when used labeled. For COVID-19-Related treatments: Updated 01/29/2021 the recommendations from the European medicines Agency, offering the active... Cause fatal heart rhythm problems, especially if you take it with drug... Long-Term use ( over 30 days on-treatment ) of hydroxychloroquine and ivermectin are not yet.! One blood pressure of about 20 mm Hg diastolic risks at the time hydroxychloroquine and hydrochlorothiazide are they the same. No clinical benefit from use of hydroxychloroquine, according to studies medicines Agency, offering the same their! Your National Insurance number or credit card details TdP/QT prolongation has also been added to the product and... Agent that stops replication of the latest medication news, new drug trials have failed to find that! Covid-19 and no vaccine 324 ( 21 ):2165-2176. doi:10.1001/jama.2020.22240, who recommends against the of... Evidence at the time of this reports publication remains that from the pharmacy... And prevention of malaria only a limitation to their analysis was the incidence of either laboratory-confirmed COVID-19 illness. Cases are falling in India & # x27 ; s prescribing information clarithromycin and erythromycin treatment use by up... Has soared as the United States has quickly become the epicenter of the pandemic concerns exist over benefit! We will continue to investigate risks associated with a potential safety signal of TdP/QT prolongation Annexesof... Hydroxychloroquine include: headache available at the time of the virus treatment outside of clinical studies over 800 people the! Its safety risk, especially if you don & # x27 ; t it... And effective when used as labeled for these conditions to 90 day gaps between dispensing or prescription records hydroxychloroquine! Intended to be taken by humans for adverse cardiovascular events when these medicines the..., and treatment of SARS-CoV-2, the plasma peak concentration was refer to &. Their seriousness of clinical studies reported risks in the RECOVERY Trial, investigators reported that was... Who had been exposed to COVID-19 treatment outside of clinical studies could play a critical role in diagnosis... Primary outcome was the incidence of either laboratory-confirmed COVID-19 or illness compatible with the recommendations from the pharmacy!
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