FDA warns against using anti-parasitic drug for Covid-19 after reports of hospitalizations - WDJT

FDA warns against using anti-parasitic drug for Covid-19 after reports of hospitalizations - WDJT


FDA warns against using anti-parasitic drug for Covid-19 after reports of hospitalizations - WDJT

Posted: 05 Mar 2021 12:00 AM PST

By Jacqueline Howard and Jen Christensen, CNN

    (CNN) -- The US Food and Drug Administration on Friday said that people should not use ivermectin to attempt to treat or prevent Covid-19. The drug is typically used to treat parasites, such as lice and scabies.

"There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in animals. The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses," the agency's announcement said on Friday.

The announcement noted that the FDA has not approved ivermectin to treat or prevent Covid-19 in humans and the drug is not an anti-viral medication.

"Taking large doses of this drug is dangerous and can cause serious harm," the announcement said, noting that even levels of ivermectin approved for other uses can interact with other medications, such as blood thinners.

"You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death."

The announcement comes just a day after new research published in the medical journal JAMA that found ivermectin did not seem to "significantly improve" the time needed for symptoms to get better among patients with Covid-19.

In January, the National Institutes of Health's Treatment Guidelines Panel said that there is not enough data to recommend for or against the drug to treat Covid-19 patients.

The drug is a cheap medication with anti-inflammatory properties and it seemed to stop the virus from replicating in lab studies -- but more research is needed to determine how the drug performs against Covid-19 in real life.

In the JAMA study based in Cali, Colombia, nearly 500 adults with mild disease who had symptoms for seven days, volunteered to help test the drug. The trial is what's known as a double-blind randomized control trial, the gold-standard of trials.

Half the volunteers received the drug for five days, the other half got a placebo, and standard care. Patients were enrolled in the trial between July 2020 and November 2020 and doctors followed up with them through December.

At the end of the trial, there were a nearly equal number of adverse events -- mostly headache -- in both groups of volunteers. The patients who got the drug said their symptoms subsided by 10 days. For the group that got the placebo, it was 12 days.

Two days was not considered a "significant" improvement.

"The findings do not support the use of ivermectin for treatment of mild COVID-19," wrote the researchers, based in Colombia. The study adds that larger trials may be needed to better understand if ivermectin provides any other kind of benefit to patients with Covid-19. In this case, the study focused on symptoms and mild disease.

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FDA Warns Against Taking Veterinary Medicine for COVID-19 - Healthline

Posted: 03 Mar 2021 12:00 AM PST

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An anti-parasitic drug should not be used for COVID-19 treatment warns experts. LUIS ROBAYO/AFP via Getty Images
  • The FDA warned that using ivermectin intended for veterinary use is dangerous and can result in severe consequences for health.
  • Many studies have been conducted to find whether ivermectin can treat COVID-19, but experts say that so far, none offers conclusive evidence.
  • Ivermectin has been used in the past as a treatment for parasitic infections in humans.

All data and statistics are based on publicly available data at the time of publication. Some information may be out of date.

Since the onset of the COVID-19 pandemic, many people have searched for a shortcut to cure the disease, which has few proven treatments.

Now the Food and Drug Administration (FDA) has issued a warning against using an antiparasite drug called ivermectin as a treatment for COVID-19.

"FDA is concerned about the health of consumers who may self-medicate by taking Ivermectin products intended for animals, thinking they can be a substitute for Ivermectin intended for humans," the FDA said in a statement. "These animal drugs can cause serious harm in people."

The FDA emphasized that people shouldn't take any form of ivermectin unless it's been prescribed to them by a licensed healthcare provider and obtained through a legitimate source.

Ivermectin was originally discovered in the 1970s and first used as a veterinary drug to kill internal and external parasites in pets and livestock. It's currently also used to treat parasite infections in people.

While considered safe for humans when used as prescribed, taking a dose intended for pets or livestock could cause severe health issues.

According to the Missouri Poison Center, there have been reports of intentional ivermectin overdoses, which can cause serious symptoms that include:

  • seizures
  • coma
  • lung and heart problems

According to the FDA, increased interest in ivermectin to treat or prevent COVID-19 infection began with the announcement of a research article. The article described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. It's important to note that ivermectin wasn't given to people or animals in this study.

The National Institutes of Health (NIH) online database of clinical trials shows 38 studies around the world that include ivermectin as a possible treatment for COVID-19.

However, according to the database, many of them are still recruiting participants and only a few are located in the United States.

The FDA emphasized that while ivermectin is being investigated in a laboratory setting, further research with conclusive data is needed before it's approved for treating COVID-19.

Critically, the FDA hasn't issued an Emergency Use Authorization (EUA) for ivermectin, which allows a drug still in testing to be used outside a clinical trial.

Mangala Narasimhan, DO, director of Critical Care Services at Northwell Health in New York, told Healthline that several randomized trials and retrospective cohort studies of ivermectin use in patients with COVID-19 have been published or made available ahead of peer review. However, evidence for it is mixed.

"Some clinical studies showed no benefits or worsening of disease after ivermectin use," she said.

She pointed out that some studies did report improvements in recuperation time reduced inflammatory marker levels or lower mortality rates in patients who received ivermectin compared to other drugs or placebos.

"However, most of these studies had incomplete information and significant methodological limitations," she explained.

According to Narasimhan, these limitations included small sample size, varying doses of ivermectin, and patients receiving other medications with treatment.

Although self-administering a drug dose intended for animals is never safe, ivermectin has helped many people when used properly as prescribed by healthcare providers.

The World Health Organization (WHO) said that drug manufacturer Merck (patent holder of ivermectin) recognized the drug's potential for human use in the 1980s. Merck began a drug donation program for river blindness (caused by a parasite) that became the global model for philanthropic partnerships between drug companies and countries unable to afford a drug.

The WHO added that ivermectin has "valuable public health applications" for controlling a disease caused by roundworms called strongyloidiasis and scabies (caused by mites).

Paul E. Marik, MD, professor of internal medicine in the Division of Pulmonary and Critical Care Medicine at Eastern Virginia Medical School, said that ivermectin is on the WHO list of essential medications. He added it's one of the safest ones available with "3.7 billion doses dispensed over the last 25 years, with minimal side effects."

The FDA warned that using ivermectin intended for veterinary use is dangerous and can result in severe consequences for health.

Many studies have been conducted to find whether ivermectin can treat COVID-19, but experts say that so far, none offers conclusive evidence.

Experts also say that when used under medical supervision, ivermectin is safe and effective for the conditions it's meant to treat and might have a role to play against the novel coronavirus.

Don't Use Veterinary Drug Ivermectin Against COVID, FDA Warns - HealthDay News

Posted: 09 Mar 2021 12:00 AM PST

[unable to retrieve full-text content]Don't Use Veterinary Drug Ivermectin Against COVID, FDA Warns  HealthDay News

Why you should not use Ivermectin to treat or prevent COVID-19 - Record Delta

Posted: 12 Mar 2021 05:37 PM PST

From the FDA

COVID-19. We've been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it's perhaps not surprising that some consumers are looking at unconventional treatments, not approved or authorized by the Food and Drug Administration (FDA). 

Though this is understandable, please beware. The FDA's job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use, and then to decide whether or not to approve it. Using any treatment for COVID-19 that's not approved or authorized by the FDA, unless part of a clinical trial, can cause serious harm. 

There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in animals.  The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.

Here's What You Need to Know about Ivermectin

  • FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an anti-viral (a drug for treating viruses).
  • Taking large doses of this drug is dangerous and can cause serious harm. 
  • If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed. 
  • Never use medications intended for animals on yourself. Ivermectin preparations for animals are very different from those approved for humans. 

What is Ivermectin and How is it Used?

Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical (on the skin) forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea. 

Some forms of ivermectin are used in animals to prevent heartworm disease and certain internal and external parasites. It's important to note that these products are different from the ones for people, and safe when used as prescribed for animals, only.

When Can Taking Ivermectin Be Unsafe? 

The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19; however, some initial research is underway. Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too.

There's a lot of misinformation around, and you may have heard that it's okay to take large doses of ivermectin. That is wrong. 

Even the levels of ivermectin for approved uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death. 

Ivermectin Products for Animals Are Different from Ivermectin Products for People

For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which can weigh a lot more than we do—a ton or more. Such high doses can be highly toxic in humans. 

Moreover, FDA reviews drugs not just for safety and effectiveness of the active ingredients, but also for the inactive ingredients. Many inactive ingredients found in animal products aren't evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don't know how those inactive ingredients will affect how ivermectin is absorbed in the human body.

Meanwhile, effective ways to limit the spread of COVID-19 continue to be to wear your mask, stay at least 6 feet from others who don't live with you, wash hands frequently, and avoid crowds.

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