Relevant News Updates
June 4, 2020: Two elite medical journals retract coronavirus papers over data integrity questions
In the first big research scandal of the COVID-19 era, The Lancet and The New England Journal of Medicine (NEJM) today retracted two high-profile papers after a company declined to make the underlying data for both available for an independent audit, following questions being raised about the research. The Lancet paper, which claimed an antimalarial drug touted by President Donald Trump for treatment of COVID-19 could cause serious harm without helping patients, had had a global impact, halting trials of one of the drugs by the World Health Organization (WHO) and others.
June 2, 2020: A mysterious company’s coronavirus papers in top medical journals may be unraveling
But just as quickly, the Lancet results have begun to unravel—and Surgisphere, which provided patient data for two other high-profile COVID-19 papers, has come under withering online scrutiny from researchers and amateur sleuths. They have pointed out many red flags in the Lancet paper, including the astonishing number of patients involved and details about their demographics and prescribed dosing that seem implausible. “It began to stretch and stretch and stretch credulity,” says Nicholas White, a malaria researcher at Mahidol University in Bangkok.
May 1, 2020: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
Today, the U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.
April 28, 2020: Why a Heartburn Drug Is Being Studied as a COVID-19 Treatment, According to Doctors
Dr. Lauver’s lab is studying the potential heart issues with several drugs touted to help with COVID-19, and he has some concerns. “While safer than chloroquine and hydroxychloroquine, famotidine is still classified as a ‘conditional risk’ for arrhythmia (irregular heartbeat),” he says. “This means that in some patients with risk factors like kidney failure, which impairs the body’s ability to clear the drug, famotidine may cause electrical changes in the heart that can cause arrhythmia.”
April 26, 2020: New York clinical trial quietly tests heartburn remedy against coronavirus
On 7 April, the first COVID-19 patients at Northwell Health in the New York City area began to receive famotidine intravenously, at nine times the heartburn dose. Unlike other drugs the 23-hospital system is testing, including Regeneron’s sarilumab and Gilead Sciences’s remdesivir, Northwell kept the famotidine study under wraps to secure a research stockpile before other hospitals, or even the federal government, started to buy it. “If we talked about this to the wrong people or too soon, the drug supply would be gone,” says Kevin Tracey, a former neurosurgeon in charge of the hospital system’s research.
April 24, 2020: Coronavirus (COVID-19) Update: Daily Roundup
Today, the FDA issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19.
APRIL 24, 2020: Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems
Today, the U.S. Food and Drug Administration issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19.
As noted in the Drug Safety Communication, the FDA has reviewed – and continues to investigate – case reports in the FDA Adverse Event Reporting System database, published medical literature and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with the antibiotic azithromycin or other medicines. These adverse events included abnormal heart rhythms such as QT interval prolongation, dangerously rapid heart rate called ventricular tachycardia and ventricular fibrillation, and in some cases, death. Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines.
April 21, 2020: Antimalarials widely used against COVID-19 heighten risk of cardiac arrest. How can doctors minimize the danger?
Jankelson and his colleagues recently measured changes in QT interval for 84 COVID-19 patients who received hydroxychloroquine and azithromycin at NYU’s Langone Medical Center. Although none went into cardiac arrest during the study, 11% had QT intervals so prolonged that they were considered at high risk of arrhythmia, the researchers reported on 3 April in a medRxiv preprint.
APRIL 21, 2020: NIH Panel Recommends Against Drug Combination Promoted By Trump For COVID-19
A panel of experts convened by the National Institute of Allergy and Infectious Diseases recommends against doctors using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients because of potential toxicities. "The combination of hydroxychloroquine and azithromycin was associated with QTc prolongation in patients with COVID-19," the panel said.
April 17, 2020: Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
The FDA, jointly with the Federal Trade Commission (FTC), previously issued a warning letter to Genesis and the FDA has warned consumers numerous times over the past decade not to purchase or drink chlorine dioxide products such as MMS sold as medical treatments. The FDA and FTC requested that the company respond within 48 hours describing the specific steps it has taken to correct the violations. In response to the warning letter, the defendants made clear that they had no intention of taking corrective action and would continue to sell MMS in violation of the law. This is especially concerning to the agency as the FDA has received reports of people experiencing serious adverse events, including respiratory failure, life-threatening low blood pressure, acute liver failure and QT prolongation after drinking certain chlorine dioxide products.
FDA Coronavirus (COVID-19) Update: Daily Roundup April 16, 2020
The FDA issued warning letters to Fishman Chemical of North Carolina, LLC., and Dr. G’s Marine Aquaculture, which distribute chloroquine phosphate products intended to treat disease in aquarium fish. Chloroquine phosphate intended to treat disease in aquarium fish has not been approved, conditionally approved, or indexed. Although neither product identified in today’s warning letters made claims about use in people, the agency is concerned that consumers may mistake unapproved chloroquine phosphate animal drugs for the human drug chloroquine phosphate, which is currently under study as a potential treatment for COVID-19. People should not take any form of chloroquine unless it has been prescribed by a licensed health care provider.
April 16, 2020: Covid-19 HCQ update: Studies in France, Brazil, China raise more questions on its efficacy, safety
Heart incidents linked to HCQ in France
France has reported 43 cases of heart incidents linked to treating Covid-19 patients with HCQ. According to a statement issued by the French drug safety agency ANSM, the country has recorded about 100 health incidents and four deaths linked to experimental drugs for Covid-19 patients since March 27. Three other patients had to be revived.
Some 82 incidents were deemed “serious.” Most of those were split between HCQ and HIV antivirals lopinavir-ritonavir.
Last month, Nigeria reported cases of chloroquine poisoning. “These drugs should only be used in hospitals, under close medical supervision,” ANSM said.
April 15, 2020: MedSafety Scan for COVID-19 Patients
AZCERT is launching an important new decision support program to help clinicians manage the risk of QT prolonging medications when treating patients with COVID-19. MedSafety Scan® is available without charge and only requires an internet connection for access. It was scheduled for launch in July, but its release has been accelerated because of the large number of people being prescribed QT prolonging drugs for COVID-19.
FDA Coronavirus (COVID-19) Update: Daily Roundup April 13, 2020
Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients:
Today, the FDA published product-specific guidances (PSGs) to support generic drug development for these drugs. The new PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary. The revised PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option.
The FDA is currently prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
FDA Coronavirus (COVID-19) Update: Daily Roundup April 8, 2020
The FDA and Federal Trade Commission (FTC) issued warning letters to three sellers of fraudulent COVID-19 products, as part of the agency’s effort to protect both people and pets. With these warning letters, the FDA is exercising its authority to protect consumers and animals from companies selling unapproved products with false or misleading claims during the COVID-19 pandemic. There are currently no approved preventatives or treatments for COVID-19. Consumers should not purchase or take any product to prevent or treat COVID-19 unless it is prescribed by a health care provider and acquired from a legitimate source.
Coronavirus (COVID-19) Update: FDA Warns Seller Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19
The U.S. Food and Drug Administration has issued a warning letter to a seller that markets fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” for prevention and treatment of “Novel Coronavirus Disease 2019” (COVID-19).
Websites selling chlorine dioxide products typically describe the product as a liquid that is 28% sodium chlorite in distilled water. Product directions instruct consumers to mix the sodium chlorite solution with citric acid – such as lemon or lime juice – or another acid – such as hydrochloric acid – before drinking. In many instances, the sodium chlorite is sold as part of a kit with a citric acid “activator.” When the acid is added, the mixture becomes chlorine dioxide, a powerful bleaching agent that has caused serious and potentially life-threatening side effects.
Life-threatening Adverse Events:
The FDA has received reports of people experiencing serious adverse events after drinking chlorine dioxide products, including:
Respiratory failure caused by a serious condition where the amount of oxygen carried through the blood stream is greatly reduced (methemoglobinemia);
Changes in the electrical activity of the heart (QT prolongation), which may lead to potentially fatal abnormal heart rhythms;
Life-threatening low blood pressure caused by dehydration;
Acute liver failure;
Low blood cell counts, due to the destruction of red blood cells faster than the body can make it (hemolytic anemia), which required a blood transfusion;
Severe vomiting; and
Severe diarrhea.The FDA is not aware of any scientific evidence supporting the safety or effectiveness of “Miracle Mineral Solution” products, despite claims that the solution has antimicrobial, antiviral and antibacterial properties. The FDA encourages consumers to talk to a health care professional about preventing and treating medical conditions or diseases.
FDA Coronavirus (COVID-19) Update: Daily Roundup April 7, 2020
Today, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg. for the treatment of: (1) Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. (2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and (3) Treatment of acute and chronic rheumatoid arthritis in adults. Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events, and hypoglycemia. The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis.
FDA Coronavirus (COVID-19) Update: Daily Roundup March 31, 2020
Today, the FDA posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis. All manufacturers are ramping up production, and the agency’s webpage displays current availability. The FDA is working with manufacturers to ensure this can happen expeditiously and safely. The U.S. Department of Health and Human Services (HHS) has also accepted 30 million doses of hydroxychloroquine sulfate to the national stockpile and one million doses of chloroquine phosphate for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. Use of the donated medications is expected to help ease supply pressures for the drugs. This is a fluctuating and dynamic situation and the FDA is actively engaged. The agency is updating its shortages lists regularly and continuing to communicate in real-time so that patients and healthcare providers have the most current information on product shortages in the U.S.
FDA Coronavirus (COVID-19) Update: Daily Roundup March 25, 2020
The FDA added hydroxychloroquine sulfate to category 1 under the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The FDA does not intend to object to registered outsourcing facilities using hydroxychloroquine (or chloroquine phosphate, which was already on category 1), to compound human drugs provided the drugs meet other conditions and requirements in the FD&C Act. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The FDA is placing hydroxychloroquine sulfate on category 1 after it reviewed the nomination and determined there was sufficient information for the agency to evaluate the substance for outsourcing facilities to use in compounding. When FDA categorized hydroxychloroquine sulfate it did not change its approach, but we prioritized this substance due to the COVID-19 pandemic. There are currently no FDA approved therapeutics or drugs to treat, cure or prevent COVID-19; however, there are FDA-approved treatments that may help ease the symptoms of COVID-19. Additionally, state-licensed pharmacies and federal facilities that compound drugs under section 503A of the FD&C Act may compound drugs using hydroxychloroquine sulfate or chloroquine phosphate bulk drug substances because they are components of an FDA-approved drug, provide other requirements in the Act are met.