Plaquenil Antiviral Medication

FDA Revokes Hydroxychloroquine’s Emergency Authorization

Don Hackett — Mon, 15 Jun 2020 17:33:50 +0000

The US Food and Drug Administration (FDA) issued a letter revoking the Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from the Strategic National Stockpile (SNS) previously issued on March 28, 2020.

The FDA letter issued by Rear Admiral Denise M. Hinton, Chief Scientist, FDA, stated on June 15, 2020, ‘today’s request to revoke (the distribution) is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 disease and that the drug’s potential benefits for such use do not outweigh its known and potential risks.’

The basis for this FDA decision includes, but is not limited to the following statements:

We now believe that the suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to produce an antiviral effect.

Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomized controlled trial assessing the probability of negative conversion showed no difference between HCQ and standard of care alone.

Current U.S. treatment guidelines do not recommend the use of CQ or HCQ in hospitalized patients with COVID-19 outside of a clinical trial and the NIH guidelines now recommend against such use outside of a clinical trial.

Furthermore, recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ (Plaquenil) treatment in hospitalized patients with COVID19.

RADM Hinton continued saying ‘While HCQ that has been distributed from SNS is no longer authorized under the EUA for the authorized use to treat hospitalized patients for COVID-19, FDA-approved HCQ can be distributed in interstate commerce.’

‘The CQ products covered by the EUA are not approved by the FDA for any indication and therefore cannot be legally introduced into interstate commerce.’

In addition, ‘under section 564(f)(2) of the Act, HCQ and CQ that were distributed from the SNS under this EUA remain authorized for emergency use to continue to treat any hospitalized patient to whom the authorized product has already been administered during the COVID-19 public health emergency, to the extent found necessary by such patient’s attending physician.’

Since early 2020, the US Centers for Disease Control and Prevention (CDC) has closely monitored the worldwide outbreak of a novel coronavirus known as SARS-CoV-2, which is causing the COVID-19 disease in humans.

The CDC announced on March 3, 2020, that a significant portion of individuals infected with the SARS-CoV-2 coronavirus lack symptoms (“asymptomatic”) and that even those who eventually develop symptoms (“pre-symptomatic”) can transmit the virus to others for several days before showing symptoms.

This means that the virus can spread between people interacting in close proximity—for example, speaking, coughing, or sneezing—even if those people are not exhibiting symptoms.

Furthermore, recent studies suggest that recovery from one SARS-CoV-2 infection might not protect a person against a second infection.

Precision Vaccinations publishes COVID-19 disease treatment news.

Sub Title:

Hydroxychloroquine may not be effective in treating COVID-19 disease

References:

Food and Drug Administration (FDA) revoke the Emergency Use Authorization for emergency use of oral formulations

Plaquenil Antiviral Medication

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The WHO Restarts Plaquenil Clinical Trial in 35 Countries

Don Hackett — Wed, 03 Jun 2020 19:03:10 +0000

Reviewer:

Robert Carlson, MD

The leader of the World Health Organization (WHO) announced they will resume testing an experimental COVID-19 disease treatment, Plaquenil.

So far, more than 3,500 patients have been recruited in 35 countries to participate in the Solidarity clinical trial.

This drug is FDA-approved to prevent or treat malaria caused by mosquito bites.

During the end of May 2020, the Executive Group of the Solidarity Trial decided to implement a temporary pause of the Plaquenil arm of the trial, because of concerns raised about the safety of the drug.

‘This decision was taken as a precaution while the safety data were reviewed,’ stated Dr. Tedros Adhanom Ghebreyesus.

‘The Data Safety and Monitoring Committee of the Solidarity Trial has been reviewing the data. On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol.’

‘The Executive Group received this recommendation and endorsed the continuation of all arms of the Solidarity Trial, including Plaquenil (hydroxychloroquine).’

‘The Data Safety and Monitoring Committee will continue to closely monitor the safety of all therapeutics being tested in the Solidarity Trial.’

‘WHO is committed to accelerating the development of effective therapeutics, vaccines, and diagnostics as part of our commitment to serving the world with science, solutions, and solidarity,’ concluded Dr.Tedros Adhanom Ghebreyesus.

On March 18, 2020, the WHO announced that it is launching the SOLIDARITY study to investigate potential therapies to treat patients with COVID-19 disease.

There are various antiviral agents, immunotherapies, and vaccines currently being developed as potential therapies for the SARS-CoV-2 coronavirus, and the disease it causes, COVID-19.

As of June 3, 2020, the US Food and Drug Administration had not approved any medication to treat the COVID-19 disease.

Precision Vaccinations publishes coronavirus treatment news.

Sub Title:

Plaquenil is considered a disease-modifying anti-rheumatic and anti-malaria drug

References:

WHO Director-General's opening remarks at the media briefing on COVID-19 - 03 June 2020

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Cancer Patients Need Coronavirus Protection Too

Don Hackett — Fri, 29 May 2020 19:43:16 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A new phase 2 clinical trial is assessing the use of an antimalaria drug for the prevention of COVID-19 disease infection among patients undergoing radiation therapy for cancer.

These researchers hypothesize that the FDA-approved Plaquenil will decrease the risk for COVID-19 infection, as there are preclinical data that show this rationale to be sound.

“Patients may be at a higher risk for contracting COVID-19 during cancer treatment due to increased exposure,” Nancy Y. Lee, MD, FASTRO, vice chairman and radiation oncologist in the department of radiation oncology at Memorial Sloan Kettering Cancer Center, said in statement published by Healio.

‘My goal in using these technologies is to improve my patients’ outcomes while decreasing potential treatment side effects and preserving their quality of life.’

‘No matter which treatment option we use, I care for all of my patients as if they were part of my family. This means creating a plan tailored to their unique disease, and doing everything I can to help them get well.’

“There is an urgent need to identify effective risk-reduction strategies for coronavirus patients who require treatment for their cancer as we await effective therapeutic options.”

“This trial will provide important insight into the potential role that Plaquenil might play in addressing this critical need.”

Plaquenil (Hydroxychloroquine) is used to prevent or treat malaria caused by mosquito bites. However, it does not work against certain types of malaria (chloroquine-resistant).

And, Plaquenil is FDA-approved for the treatment of rheumatoid arthritis, systemic lupus erythematosus, and porphyria cutanea trade.

In this phase 2 clinical trial, every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of Plaquenil 400mg daily.

The placebo used in this study is a tablet that looks the same as the study drug and is taken in the same way, but it does not contain any active ingredients.

According to a related study published on March 27, 2020, patients with cancer are known to be at an increased risk for community-acquired respiratory viruses, such as influenza, because of their frequently observed immunocompromised state.

The spread of SARS-CoV-2 is of particular concern in this vulnerable population, given the higher case fatality rate seen around the world and the potentially increased severity of the disease course with COVID-19.

Radiation oncologists will also have to prepare for treatment interruptions caused by the development of COVID-19 disease in patients with cancer.

Patients who test positive for the novel coronavirus will, at a minimum, require a 14-day quarantine.

At the other end of the spectrum, patients with cancer with immunosuppression may require hospitalization and isolation precautions, thus preventing the continuation of radiation treatments.

Coronavirus Today publishes treatment development news.

Sub Title:

Radiation oncologists prepare for cancer treatment interruptions caused by COVID-19 disease infections

References:

A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy

The Impact of COVID-19 on Radiation Oncology Clinics and Patients With Cancer in the United States

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Lupus Patients Frustrated Refilling Plaquenil

Don Hackett — Thu, 28 May 2020 17:00:22 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

About 31 percent of people diagnosed with lupus experienced significant issues trying to fill their Plaquenil prescriptions during the COVID-19 disease pandemic according to a new survey conducted by the Lupus Research Alliance (LRA).

The LRA announced on May 28, 2020, there were Plaquenil (hydroxychloroquine) medication shortages reported in 42 US states, the District of Columbia, and Puerto Rico began during March and April 2020.

The new survey included 334 people with lupus living in the USA who had already been taking Plaquenil to manage symptoms related to this difficult autoimmune disease, said the LRA.

The survey queried people with lupus on their experiences from March 1 through May 18, 2020, and found:

Survey respondents had been taking Plaquenil for an average of 11.4 years
31% of people surveyed had issues getting refills
5% were not able to refill their prescriptions during this time frame
Of the 36% who were not able to or had issues with refills
- 66% had enough to take full dose
- 33% split doses
- 9% were completely out
Of the 72 people who reported eventually being able to get their refills
- 36% could not get it from their regular pharmacy
- 58% reported it taking 2+ weeks to get their refills

One person wrote to the LRA stating: "I tried to refill my Plaquenil prescription, but they said I can only have two weeks' worth. So, I'm taking what's left of that allotment and will try again to refill."

Another survey respondent was only able to fill her prescription after 3-weeks of calling different pharmacies.

A 3rd person reported that her physician advised splitting her regular Plaquenil dose in half until the supply shortage abated.

Dr. Gary Koretzky, Vice Provost for Academic Integration, Cornell University, Professor of Medicine at Weill Cornell Medicine, and Chair of the Lupus Research Alliance Scientific Advisory Board, said in a press statement, "To help alleviate and prevent a similar situation in the future, the LRA has emphasized to the U.S. Food and Drug Administration (FDA) and other government agencies how the Plaquenil shortage impacted people who rely on the drug.”

"We were pleased to put this issue on the radar for our colleagues at the FDA as it is clear that there is interest in closely monitoring how patients with lupus are faring."

Dr. Koretzky added that the LRA is also aware of media reports about Plaquenil side effects reported in COVID-19 patients.

He urged lupus patients prescribed Plaquenil "to remember that their rheumatologists have suggested this medication because of its effectiveness in treating disease and its well-demonstrated safety profile."

He cautioned that patients should certainly discuss their personal situation with their physician before discontinuing this or any other medication.

"The survey results offer real-world data about the access of lupus patients to Plaquenil," said LRA Chief Scientific Officer, Dr. Teodora Staeva.

“We still recommend that people with lupus speak with their healthcare providers about a contingency plan should any shortages arise in the future."

Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women.

Lupus most often strikes during the childbearing years of 15-45.

African Americans, Latins, Asians, and Native Americans are up to 3x at greater risk of Lupus than Caucasians, says the LRA.

In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.

The symptoms of lupus also differ from person to person.

For example, one woman with lupus may have swollen knees and fever. Another woman may be tired all the time or have kidney trouble. Someone else may have rashes.

Over time, new symptoms can develop or some symptoms may happen less often.

Lupus symptoms also usually come and go, meaning that you don’t have them all of the time, says the LRA.

The Lupus Research Alliance aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world.

Precision Vaccinations publishes Lupus treatment news.

Sub Title:

Plaquenil prescriptions for lupus in short supply during coronavirus outbreak

References:

COVID-19 Caused Hydroxychloroquine Issues for Third of Lupus Patients, New Lupus Research Alliance Survey Finds

Racial/Ethnic Variation in All‐Cause Mortality Among United States Medicaid Recipients With Systemic Lupus Erythematosus: A Hisp

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Close Supervision Needed for ‘Off-Label’ Antimalarial Drug Use

Don Hackett — Fri, 24 Apr 2020 19:44:33 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Danielle Reiter, RN

The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine that have been reported with their use for the treatment or prevention of COVID-19 disease.

As of April 24, 2020, these products are FDA-approved to treat or prevent malaria, and Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis.

But they are not approved to treat COVID-19 patients.

“We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” said FDA Commissioner Stephen M. Hahn, M.D.

“While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered.”

“We encourage healthcare professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks.”

“The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”

These medicines have not been proven safe or effective for treating COVID-19. However, clinical trials are underway and additional trials are being planned to determine if these drugs can benefit patients with COVID-19.

These trials are also examining whether the drugs can prevent COVID-19 among health care workers, first responders, or people who have been in close contact with someone with COVID-19.

Once the FDA has approved a drug, health care providers generally may prescribe or administer the drug for an unapproved use, including in clinical settings not described in the approved labeling. This decision will be based on their assessment of the potential benefits versus the risks for their patient, recognizing that the FDA has not assessed the safety or effectiveness of such use.

For this reason, it is important that health care providers are aware of the risks of serious and potentially life-threatening heart rhythm problems that can occur with these drugs and are included in the drug labels for their approved uses.

The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:

Complete and submit the report online or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

SARS-CoV-2 pandemic news published by CoronavirusToday.

Sub Title:

FDA encourages healthcare professionals to make individual patient decisions to mitigate health risks

References:

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial

COVID-19 Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate

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India Minimizes Hydroxychloroquine Export Ban

Don Hackett — Tue, 07 Apr 2020 17:37:14 +0000

Reviewer:

Robert Carlson, MD

India has decided to partially lift the export ban of the antimalarial drug hydroxychloroquine, a New Delhi health officials said on April 7, 2020.

This is an important announcement since India is the largest producer of the drug globally.

Previously, India had banned the export of hydroxychloroquine on March 25, 2020.

Reacting to the government''s decision to partially lifting the ban, Congress leader Rahul Gandhi said ‘India must help all countries in their fight against coronavirus, but lifesaving medicines should be made available to Indians first.’

"India must help all nations in their hour of need but lifesaving medicines should be made available to Indians in ample quantities first," he said on Twitter.

Hydroxychloroquine is an old and inexpensive drug used to treat malaria.

"India has always maintained that the international community must display strong solidarity and cooperation. This approach also guided our evacuation of nationals of other countries," spokesperson in the Ministry of External Affairs Anurag Srivastava said.

"After having confirmed the availability of medicines for all possible contingencies currently envisaged, these restrictions have been largely lifted," he said.

"With regard to paracetamol and hydroxychloroquine, they will be kept in a licensed category and their demand position would be continuously monitored," Srivastava said.

"However, the stock position could allow our companies to meet the export commitments that they had contracted," he added.

According to an advisory distributed from New Delhi on March 22, 2020, hydroxychloroquine should be given to high-risk population -- asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 disease and asymptomatic household contacts of laboratory-confirmed cases.

As of April 7, 2020, reporting services confirmed about 150 fatalities related to COVID-19 disease during 2020.

Recently, the U.S. Food and Drug Administration (FDA) issued emergency use authorization of Hydroxychloroquine for the treatment of coronavirus patients.

Previously available for “off-label” use, the FDA now gives hospitals and doctors emergency permission to use the anti-malarial drugs hydroxychloroquine and chloroquine to treat coronavirus patients.

Furthermore, a global survey found that hydroxychloroquine was the most highly-rated treatment against COVID-19 disease.

This survey completed by Sermo on March 27, 2020, found 37 percent of healthcare providers treating COVID-19 patients rated hydroxychloroquine as the “most effective therapy” from a list of 15 options.

COVID-19 medication news published by Precision Vaccinations.

Sub Title:

Hydroxychloroquine exporting authorized depending on India domestic requirements

Reference:

COVID-19: India to export hydroxychloroquine on case-by-case basis; Rahul Gandhi says ensure Indians get it first

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Doctors Rate Hydroxychloroquine Most Effective Therapy for Coronavirus Infection

Don Hackett — Sat, 04 Apr 2020 11:33:16 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A global survey found that anti-malarial drug hydroxychloroquine was the most highly-rated treatment against the coronavirus disease 2019 (COVID-19).

This new survey completed by Sermo on March 27, 2020, reported 6,227 physicians in 30 countries found that 37 percent of those treating COVID-19 patients rated hydroxychloroquine as the “most effective therapy” from a list of 15 options.

Also, the survey of 6,227 doctors found that the most commonly prescribed treatments are 56% analgesics, 41% Azithromycin, and 33% Hydroxychloroquine.

Previously, a survey distributed on March 30, 2020, about 83 percent of independent pharmacists in the USA said ‘they should be able to dispense a limited supply of malaria drugs, as long the patient has tested positive ..... and is under a doctor's care.’

And, on March 23rd, the U.S. Food and Drug Administration (FDA) issued emergency use authorization of Hydroxychloroquine for treatment of coronavirus patients.

Below is a summary of the findings from the Sermo survey:

Hydroxychloroquine usage amongst COVID-19 treaters is 72% in Spain, 49% in Italy, 41% in Brazil, 39% in Mexico, 28% in France, 23% in the US, 17% in Germany, 16% in Canada, 13% in the UK and 7% in Japan.
Hydroxychloroquine was overall chosen as the most effective therapy from a list of 15 options (37% of COVID-19 treaters).
75% in Spain, 53% in Italy, 44% in China, 43% in Brazil, 29% in France, 23% in the US and 13% in the UK.
The two most common treatment regimens for Hydroxychloroquine were: (38%) 400mg twice daily on day one; 400 mg daily for 5 days. (26%) 400mg twice daily on day one; 200mg twice daily for 4 days.
Outside the US, Hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the US it was most commonly used for high risk diagnosed patients.
Globally, 19% of physicians prescribed or have seen Hydroxychloroquine prophylactically used for high-risk patients, and 8% for low-risk patients.

As of April 4, 2020, data sources indicate there have been over 1.1 million cases of the SARS-CoV-2 coronavirus reported by countries around the world.

Clinical data evaluating hydroxychloroquine is limited, and its efficacy against SARS-CoV-2 is unknown. Nevertheless, given the lack of clearly effective interventions and the in vitro antiviral activity against COVID-19 some clinicians are using it. There are cardiac side effects among its side effects.

Moreover, there have been about 59,203 fatalities confirmed related to the COVID-19 disease during 2020.

SARS-CoV-2 outbreak news is published by Coronavirus Today.

Precision Vaccinations publishes COVID-19 therapeutic development news.

Sub Title:

FDA issued emergency authorization of Hydroxychloroquine treatment for COVID-19 patients in the USA

References:

Breaking Results: Sermo’s COVID-19 Real Time Barometer Study

Most Pharmacists Recognize Malaria Drug’s Therapeutic Value

Hydroxychloroquine

Pharmacists Now Authorized to ‘Compound’ Hydroxychloroquine Sulfate

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Hydroxychloroquine Clinical Benefits Become Clearer

Don Hackett — Thu, 02 Apr 2020 11:41:26 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The accelerating debate about the clinical benefit of treating COVID-19 disease patients with hydroxychloroquine became a little bit clearer with a new study.

Previous studies have indicated that chloroquine (CQ) shows antagonism against COVID-19 in vitro.

As a derivative of CQ, hydroxychloroquine (HCQ) is reported to offer similar therapeutic effects, but with fewer adverse effects.

However, the scientific evidence regarding this antimalarial drug efficacy in COVID-19 patients is limited, since it is a new disease.

A new, small, non-peer-reviewed clinical study published on March 31, 2020, evaluated the efficacy of hydroxychloroquine (HCQ) in the treatment of patients with COVID-19 in China.

From February 4 to February 28, 2020, 62 patients suffering from COVID-19 were diagnosed and admitted to the Renmin Hospital of Wuhan University, located in China.

All participants were randomized in a parallel-group trial #ChiCTR2000029559, 31 patients were assigned to receive an additional 5-day HCQ (400 mg/d) treatment, Time to clinical recovery (TTCR), clinical characteristics, and radiological results were assessed at baseline and 5 days after treatment to evaluate the effect of HCQ.

This study’s key findings were:

For the 62 COVID-19 patients, 46.8% (29 of 62) were male and 53.2% (33 of 62) were female, the mean age was 44.7 (15.3) years. No difference in the age and sex distribution between the control group and the HCQ group.
But for TTCR, the body temperature recovery time and the cough remission time were significantly shortened in the HCQ treatment group.
Besides, a larger proportion of patients with improved pneumonia in the HCQ treatment group (80.6%, 25 of 32) compared with the control group (54.8%, 17 of 32).
Notably, all 4 patients progressed to severe illness that occurred in the control group.
However, there were 2 patients with mild adverse reactions in the HCQ treatment group.

The significance of this limited study’s findings is that ‘among patients with COVID-19, the use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia.’

However, larger-scale clinical research is needed to clarify HCQ’s specific mechanism and to continuously optimize the treatment plan for COVID-19 patients, said these researchers.

This study was supported by the Epidemiological Study of COVID-19 Pneumonia to Science and Technology Department of Hubei Province (2020FCA005). And, the authors did not declare any competing interest.

Note: Non-peer-reviewed medical research means it has yet to be clinically evaluated by other health professionals, and therefore, should not be used to guide clinical practice.

COVID-19 disease therapeutic treatment news published by Precision Vaccinations.

Sub Title:

Hydroxychloroquine reduces time to clinical recovery when treating COVID-19 disease patients

References:

Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial

Therapeutic effect of hydroxychloroquine on novel coronavirus pneumonia (COVID-19)

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