What is a Novel Virus?

In the earlier days of the current coronavirus outbreak, there were many questions about the nature of the virus and whether it was similar to or a type of seasonal flu. While many of the symptoms may be similar and overlap, one key distinction is that while there are many more and varied strains of the seasonal flu (influenza A or B) from season to season and the human population has been exposed to influenza viruses for centuries.

Since the "Spanish Flu" pandemic of 1918, which led to an estimated 50 million deaths worldwide, researchers and scientists have had more than a century to study how different strains of influenza develop, mutate, and move through human populations. Getting the flu one winter won’t necessarily protect you from contracting a different strain the following season, and some seasons can be much worse than others. With that said, the medical community understands how the flu works, what to expect, and how to treat patients from season to season to manage infection and mortality rates.

A novel virus means that it's completely new to the human population, so not only is there no natural immunity to the virus in many people, but there is little to no reputable data on how the virus will behave, or how to treat it effectively in time to avoid a pandemic such as the SARS (severe acute respiratory syndrome) outbreak in 2003, the H1N1 outbreak in 2009, and now COVID-19.

Developing Medications and Treatments for Novel Viruses

Unfortunately, there are no blanket or "one size fits all" treatments and prescriptions available for new illnesses like the novel coronavirus. The most common approach to finding a viable treatment is through the development of vaccines and new drugs, which can take years (and in some cases decades), or by repurposing existing medications already in development or on the market for a different illness or condition.

At the moment, pharmaceutical companies, governmental organizations, and public health institutions like The World Health Organization (WHO) are organizing a number of clinical trials and studies to find new approaches for treating COVID-19.

Even under the best of circumstances, new drugs and vaccines must undergo clinical trials to test for human safety and efficacy, which typically span from 18 months to three years, depending on the trial.

Health regulators worldwide, including the Food and Drug Administration (FDA) in the USA, generally don’t provide blanket approval for prescription drugs for any every use. So even though a drug like Plaquenil (hydroxychloroquine) has already been approved to treat specific conditions like lupus or malaria, it will still require new research and clinical trials before it can be approved and safely prescribed for a new illness like COVID-19.

There are many prescription drugs currently on the market which were originally studied for one condition, only to prove effective in other areas. Viagra, which was originally developed and tested for high blood pressure and angina, is one of the most famous examples.

According to the FDA's prescription drug development and approval process, there are different avenues towards approval depending on a number of factors such as the drug’s known risks and side effects vs. its therapeutic benefits. In some cases, drug approval can be fast tracked to get it on the market sooner.

Fast tracking approval of a drug: the FDA allows drug companies to apply for fast track status to get essential drugs and therapies to market as quickly as possible, but there are many factors and conditions that must be met before approval is granted, such as data proving the drug’s effectiveness for the intended illness, as well as a reasonable safety record. It is not a shortcut around clinical or safety standards.

Breakthrough therapy designation: A drug may receive fast track approval and be designated as a breakthrough therapy if it shows promise for treating a serious illness and improves on the effectiveness of an existing approved drug, but a number of conditions need to be met and it’s not a rubber stamp for untested drugs or treatments.

Priority review: With a priority review, the standard FDA approval window is shortened from an average of ten months to approximately six months.

Has the FDA Approved Plaquenil or Hydroxychloroquine for Novel Coronavirus Treatment?

At the moment, the FDA has not approved any prescription drugs or therapies for COVID-19, including Plaquenil or hydroxychloroquine. There are numerous clinical trials underway for new and existing drugs like hydroxychloroquine as possible treatments, but the trials are ongoing.

(Note: While the FDA has granted an "EUA" or Emergency Use Authorization for Plaquenil, that is not the same as "approval.")

According to the Centers for Disease Control and Prevention (CDC), the FDA has granted limited access of hydroxychloroquine from the Strategic National Stockpile to the U.S. Department of Health and Human Services (HHS) under the Emergency Use Authorization Act (EUA) under the following conditions:

Clinical trials and the approval process for new prescription drugs and therapies are conducted under highly controlled and regulated environments, so even if a trial shows early promise, it doesn't mean that doctors can prescribe it to the general public before it has been approved, even during a pandemic.

What Does Plaquenil Actually Treat?

Plaquenil and hydroxychloroquine are synthetic derivatives of quinine, which has been in use in some capacity to treat malaria for centuries. In recent years, anti-malarial drugs like hydroxychloroquine and Plaquenil have also been prescribed to treat autoimmune and inflammatory disorders like lupus and rheumatoid arthritis, which affects over one million Americans and millions more around the world every year.

General Risks and Possible Side Effects of Plaquenil

There are several problems and dangers associated with taking Plaquenil, hydroxychloroquine, or any medication or treatment without a prescription. At best, the medication won’t work and will be a waste of money. At worst, you may experience serious side effects that could put your health and even your life at risk, ranging from overdose, harmful interactions with other drugs and medications, and death in extreme cases.

Without definitive results from controlled clinical trials, it’s simply too early to know whether hydroxychloroquine will be safe and effective to treat conditions outside of its current approval for malaria and rheumatic disorders.

Even when taken as prescribed, all prescription drugs and medications have potential side effects. Plaquenil is no exception. While some people may take hydroxychloroquine as prescribed with little to no side effects, others can experience a range of complications ranging from mild to severe.

When prescribing a medication, doctors must weigh the potential benefits against the known risks of the drug’s side effects. While it can be impossible to predict how an individual will react to any given drug, your personal history and health play a key role in determining whether the benefits will outweigh the risks of taking the medication. This is why it’s so important to only take medications that have been prescribed to you by a trusted and licensed physician, and to follow the instructions and dosage information .

Some of the most common side effects of hydroxychlorquine (when taken as prescribed) include:

Though typically rare, some people taking Plaquenil may experience serious side effects including infections, low blood sugar (hypoglycemia), vision problems (photosensitivity, blurred vision, diminished vision), cardiovascular problems (irregular heartbeat, shortness of breath).

In addition to side effects, many otherwise harmless and beneficial medications can cause serious or even fatal complications when mixed with other drugs. This is especially important for patients in the United States, many of whom take multiple prescription drugs at a time to manage chronic conditions according to the CDC. Outside of a doctor's supervision, it can be impossible to know how certain prescription drugs will interact with one another.

Certain prescriptions will just cancel each other out, making them less effective or not effective at all, which may not pose a serious health risk depending on the medication and your health. On the other end of the spectrum, some drug interactions can cause life threatening complications or even death.

The Dangers that Hydroxychloroquine Shortages Pose to Lupus Patients

From a public health perspective, stockpiling medications often result in shortages for the people who really need them. Despite the fact that the FDA has not approved Plaquenil for coronavirus treatment, shortages of the drug are already being reported, and patients with lupus who rely on the drug to manage their illness are already having difficulty filling their monthly prescriptions.

Lupus is a chronic and progressive disorder where the immune system attacks healthy organs and tissues, leading to potentially serious and even life-threatening complications over time. Unlike malaria which can also be life threatening but is typically acute and eventually clears up with treatment, most lupus patients have to take medications like hydroxychloroquine to manage and keep their symptoms at bay for the rest of their lives.

Hydroxychloroquine is the most commonly prescribed drug for lupus because in addition to managing symptoms and flare ups, it also complements many of the other medications that lupus patients may have to take to control their disease. As a chronic condition, lupus patients require long term care, and uninterrupted access to medication is critical to their health and wellbeing. Even if a healthy person takes hydroxychloroquine without experiencing any side effects, the resulting shortage could literally be life threatening for someone who needs to take the drug for lupus or malaria.

Likewise, there are other autoimmune conditions that are often treated with hydroxychloroquine. Conditions like rheumatoid arthritis, Sjögren syndrome, and post-Lyme arthritis are all treated with hydroxychloroquine. With these diseases, like Lupus, it’s expected that patients will be on the drug for the rest of their life.

For many individuals, living without their drug is simply not an option. Not only could it lead to a decreased quality of life, but it also could lead to a dangerous deterioration of their health and symptoms.

While it's understandable to seek out cures during scary times, it’s also important that we keep everyone in mind when responding to a crisis. Not only may Plaquenil not be the silver bullet that was initially promised, but a shortage might severely hurt many, many vulnerable Americans.

Our customer service team is available to answer all of your questions about whether you can buy hydroxychloroquine online and the process for ordering prescription medications from a reputable international and Canadian online pharmacy. For more information, call our toll free number 1-866-539-5330 to speak with a representative, or you can also contact us online.