Hydroxychloroquine Prescriptions, the Food and Drug Administration, Sars-V2 virus, and COVID-19 Disease.
Since the outbreak of the Sars-V2 virus, Covid-19 disease, there has been a lot of confusion regarding which medical products will work to treat the virus. Much work is being done to develop drugs for the Sars-V2 virus and Covid-19 disease, and the FDA is searching for a drug or combination of drugs that prove to be effective. Some drugs are in clinical trials, and scientists are also testing whether a drug approved for another virus or disease will be safe and effective for Sars-V2 and COVID-19. This is called “off-label prescription.” Healthcare providers might use these drugs for Sars-v-2/Covid-19 patients as off label prescription use.
What is FDA Approved?
When the FDA approves a drug, it means that the drug is safe and effective based on evidence gathered, and the benefits outweigh the risks. Before the FDA approves a drug, it must analyze the clinical data and other information to show that the drug is safe and effective for its intended use and that the product can be made according to federal quality standards. Scientists conduct a clinical trial to study drugs and to demonstrate their effectiveness and safety. They check its suitability and effectiveness against the disease, the safety of drugs for the patients, the dosage, and the cost-benefit analysis.
Expanded Access and EUA by FDA
Expanded access allows patients with severe and life-threatening situations to have access to experimental drugs that are not available for public use or used outside a clinical trial. They can only have access to such medications if there are no suitable alternatives. Moreover, An Emergency Use Authorization (EUA) is a method used by the FDA to make certain drugs available during pandemics when there are no approved medications available. The EUA is different than FDA approval because, under EUA, the urgent availability of drugs is authorized based on the best available evidence. For example, a clinical trial showed that remdesivir might benefit COVID patients; therefore, the FDA approved the use of remdesivir under a EUA for severe COVID patients.
Off Label Prescription use by the Food and Drug Administration – FDA
Once the FDA approves a drug, healthcare providers may, at their discretion, prescribe the drug for unapproved use not described in the approved labeling (off label prescription use) based on their expertise and judgment. For example, hydroxychloroquine (HCQ) is FDA approved to treat malaria, lupus, and arthritis, but some medical experts are prescribing it for treating COVID. However, since the clinical trials have just started, the FDA is waiting for the scientific data that will demonstrate the safety and effectiveness of HCQ in treating Sars-V2 and Covid-19. The FDA has issued an Emergency Use Allowance -EUA to allow access of HCQ from Strategic national Stockpile for the treatment of particular Sars-V2/Covid-19 patients who are not liable for clinical studies. HCQ is available nationwide, and it is distributed for its approved uses, and they may be prescribed for off label (non-labeled) uses too like for the treatment of Sars-V2/Covid-19 patients.
Doctor’s Perspective to the FDA Response Regarding HCQ Use for Sars-V2/COVID-19
The Purpose of the Food and Drug Administration
Doctors are doing a lot of research around the world to find a solution for the virus. FDA’s primary concern is for the health of American people. Their team of about 18,000 doctors is using their years of expertise to make decisions based on the best data to respond to this global emergency. The FDA plays a prime role in providing potential treatment options to prevent diseases. Likewise, they are working to provide new medical products to patients as soon as possible, and at the same time, they determine the cost-benefit analysis of the medication. For example, the FDA issued a EUA for the antiviral drug remdesivir and allowed plasma therapy for COVID patients. The technical terms may be confusing, but public interest pointed towards FDA work to ensure safe treatment options for the Covid-19.
Off-label Use of HCQ by FDA
Dr. Stephen M. Hahn, the Commissioner of the Food and Drugs – Food and Drugs Administration, said in his account that doctors consider off label uses of drugs if it is the best in the interest of patients. He highlighted this as a common practice in medicine, and in fields of oncology and brain health, many patients are treated through this method. Dr. Stephen further stated that these off-label medications are discussed with the patients beforehand. The risks are also discussed, as well as the pathway of the treatment recommended. Furthermore, Dr. Stephen emphasized that the drug HCQ is receiving a lot of attention, and it is being studied to tests its effectiveness against the virus. The drugs are FDA approved for malaria, lupus, and arthritis, and they have been prescribed for these deadly diseases, and they have a safe profile for these conditions. Many physicians have prescribed HCQ for COVID patients based on their judgment. Dr. Stephen further stated that the FDA does not regulate the practice of medicine, but they provide info to the physicians about HCQ, so they make a better decision. The agency neither endorses individual prescribing decisions nor prohibits physicians from prescribing medications. It was deducted from the trials that early prophylaxis of HCQ would help in the treatment of viruses.
FDA Approval for HCQ
To meet the evolving demands of the pandemic, the FDA also issued a EUA that allowed for additional supplies of approved hydroxychloroquine and that was tested by the FDA and donated to the Strategic National Stockpile to be used in the treatment of certain patients hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible. Dr. Stephen further said that this decision was based on the best available evidence and under the EUA criteria. Future determinations will be made as soon as new evidence is available from the clinical trials. Since HCQ is FDA approved for other uses, the donation agreement allowed it to be distributed for clinical trials and outpatient settings. As healthcare providers continue to research for the best available cure for Covid-19, the FDA will always use the best available evidence to urgently address the emergency.
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HCQ is in a class of drugs called antimalarial, and it is FDA approved for the treatment of acute attacks of malaria. It is also used for the treatment of immunodeficiency diseases such as lupus and arthritis. Hydroxychloroquine has been an approve FDA drug for about 70 years with almost no known side effects. There is a lot of media attention on Hydroxychloroquine’s use in relation to Sars-V2 and Covid-19. Many doctors are prescribing it and seeing positive results while others are waiting for FDA approval.
Both are antimalarial drugs, and they are quite similar. The brand name for HCQ is Plaquenil, whereas it is Aranel for Chloroquine. They both are used to treat several forms of malaria, and HCQ is used in addition to treating lupus and arthritis, whereas Chloroquine is used off label to treat porphyria.
HCQ comes in a tablet form, and it is to be administered orally. If you are taking it to prevent malaria, one dose is usually taken on the same day of each week. It is usually taken once or twice a day for lupus and arthritis. If an adult is traveling to a place where malaria is common, HCQ is indicated for prophylaxis of malaria. The medication is started two weeks before exposure and continues till four weeks after departure from the endemic area. The use of HCQ for Sars-V2 or Covid-19 should only be taken with a Doctors prescription.
One tablet of HCQ typically contains 200 mg HCQ. For malaria prophylaxis, the dosage could be 400 mg and is to be taken orally once a week. For acute malaria, higher mg doses can be taken as an initial dose, followed by doses taken at 6, 24, and 48 hours after the initial dose. For lupus, it could be 200-400 dose per day be divided into one or two doses. For arthritis, it can be prescribed to take 400-600 mg as initial dosage, and for maintenance, 200-400 gm dose should be taken per day.
Take the dose as soon as you remember it. If it is time for the next dose, then skipped dose should be missed, and regular dosing should be followed. Double dosing should not be taken to make up for a missed dose.
HCQ can be prescribed by a doctor and can only be purchased through a pharmacy with a doctor’s prescription. In the US, it cannot be bought over the counter, and a doctor’s prescription is required.
The cost of HCQ tablets generally ranges from $0.37 to $0.99. DoctorsHome is not a pharmacy, but the pharmacies that are connected to the online doctor’s network provide the most competitive pricing for HCQ. Feel free to talk to a doctor and get your questions and concerned answered if HCQ is right for you.
This is a question only a doctor can provide more insight into. There are too many variables to know how fast hydroxychloroquine will work and benefit you.
Hydroxychloroquine has been approved by the FDA for about 70 years with practically no major side effects. It is rare to experience any side effects, but HCQ may cause headaches, nausea, rashes, diarrhea, and visual problems. Healthcare providers will prescribe a safe dosage according to the patient weight, and the patient is required to regularly monitor their eyes.
Many scientists have tested HCQ for the treatment of Sars-V2 and Covid-19. Some doctors are looking at prophylaxis use of HCQ to help in a reduction in hospitalization rates and reduced the death rate. Also, many doctors have stated that the use of HCQ with zinc and azithromycin has shown promising results, and these medications can be used for treating Sars-V2 and Covid-19 patients. However, as of August 2020, HCQ is not FDA approved for the treatment of Covid, but still, FDA issued a EUA to allow HCQ for the treatment of Sars-V2 and Covid-19 based on best available evidence and at the doctors discretion. Based on ongoing clinical trials of Hydroxychloroquine results, the FDA will take action regarding the use of HCQ for Sars-V2 and Covid-19 once those clinical trials are completed.