Farm supply and feed stores cannot keep a livestock deworming medication on the shelves because social media posts are calling it a cure for COVID-19. A veterinarian with the Alabama Cooperative Extension System warns that people should not buy animal ivermectin products to self-medicate.
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“Animal formulations of ivermectin are not safe for human use,” said Soren Rodning, who is also an Auburn University associate professor of animal sciences. “Bottom line—do not self-medicate with animal ivermectin products. I cannot emphasize this enough.”
The Alabama Poison Information Center at Children’s of Alabama has fielded more than two dozen ivermectin exposure calls so far. The majority of these calls were related to COVID-19.
Possibly lethal to humans
The Food and Drug Administration requires labels on animal ivermectin products warning people not to ingest it. Veterinarians use it as a dewormer in cattle, horses and pets.
“The concentration of ivermectin in these products or some of the inactive ingredients used in animal formulations may not be safe for human use,” he said. “Specifically, these have not been proven safe for use by people through clinical drug trials.”
Marilyn Bulloch, an Auburn University associate clinical professor of pharmacy practice, adds that while a human formulation of ivermectin exists, safety is key.
“It would be wonderful to have a cheap oral medicine to treat COVID,” said Bulloch. “But the blood concentrations needed for the active ingredient are substantially higher than ever studied and is not safe in humans. Research shows that it does not work in normal human doses.”
Bulloch’s colleague, Spencer Durham, agrees.
“To achieve adequate blood concentrations would require a lethal dose of the human formulation,” said Durham, who is also an associate clinical professor of pharmacy practice at Auburn.
Current studies
Bulloch and Durham also point out that hundreds of drugs have shown promise in a lab setting against COVID-19 but failed to be effective against the disease in people.
“Currently, there is a well-designed, large-scale study in people underway in the United Kingdom to investigate if ivermectin could be effective in more normal human doses,” said Bulloch. “But we do not know how long that study will run and when the data will be available.”
Durham said that long-term studies into dose sizes, dosing schedules and potential side effects in people are what is needed.
“These types of studies are what we need to make well-researched and safe recommendations,” he said.
Additionally, Durham is concerned that vaccine-hesitant people are embracing the social media hype around ivermectin.
“I understand that people want to feel that any medications and vaccines are well-researched and safe,” he said. “But there is no evidence to support that normal doses of human formulations of ivermectin are effective and significant evidence that animal formulations are not safe for people and possibly lethal.”
Durham said in contrast, strong evidence exists that the vaccines currently available are safe and significantly reduce the potential for contracting COVID-19 and requiring hospital treatment if a person does get the disease.
How to fight COVID-19
Rodning, Bulloch and Durham also agree that following a few key steps provide the strongest defense against COVID:
More information
KENILWORTH, N.J., Feb. 4, – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today affirmed its position regarding use of ivermectin during the COVID-19 pandemic. Company scientists continue to carefully examine the findings of all available and emerging studies of ivermectin for the treatment of COVID-19 for evidence of efficacy and safety. It is important to note that, to-date, our analysis has identified:
We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.
Indications and Usage for STROMECTOL® (ivermectin)
Ivermectin is approved in the United States under the brand name STROMECTOL. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis and for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.
STROMECTOL has no activity against adult Onchocerca volvulus parasites.
SELECTED SAFETY INFORMATION FOR STROMECTOL® (ivermectin)
Contraindications
STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.
Warnings and Precautions
Patients treated with STROMECTOL for onchocerciasis may experience cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions.
After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis.
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Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: pain (including neck and back pain), red eye, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, seizures, or coma. In individuals who warrant treatment with ivermectin for any reason and have had significant exposure to Loa loa-endemic areas of West or Central Africa, pretreatment assessment for loiasis and careful post-treatment follow-up should be implemented.
STROMECTOL should be taken on an empty stomach with water.
Strongyloidiasis: The patient should be reminded of the need for repeated stool examinations to document clearance of infection with Strongyloides stercoralis.
Onchocerciasis: The patient should be reminded that treatment with STROMECTOL does not kill the adult Onchocerca parasites, and therefore repeated follow-up and retreatment is usually required.
Adverse Reactions
Strongyloidiasis
In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of STROMECTOL, the following adverse reactions were reported as possibly, probably, or definitely related to STROMECTOL: Body as a Whole: asthenia/fatigue (0.9%), abdominal pain (0.9%); Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%); Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%); Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
Onchocerciasis
In clinical trials involving 963 adult patients treated with 100 to 200 mcg/kg STROMECTOL, worsening of the following Mazzotti reactions during the first 4 days post-treatment were reported: arthralgia/synovitis (9.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%).
In clinical trials, ophthalmological conditions were examined in 963 adult patients before treatment, at day 3, and months 3 and 6 after treatment with 100 to 200 mcg/kg STROMECTOL. Changes observed were primarily deterioration from baseline 3 days post-treatment. Most changes either returned to baseline condition or improved over baseline severity at the month 3 and 6 visits. The percentages of patients with worsening of the following conditions at day 3, month 3 and 6, respectively, were: limbitis: 5.5%, 4.8%, and 3.5% and punctate opacity: 1.8%, 1.8%, and 1.4%. The corresponding percentages for patients treated with placebo were: limbitis: 6.2%, 9.9%, and 9.4% and punctate opacity: 2.0%, 6.4%, and 7.2%.
In clinical trials involving 963 adult patients who received 100 to 200 mcg/kg STROMECTOL, the following clinical adverse reactions were reported as possibly, probably, or definitely related to the drug in ³1% of the patients: facial edema (1.2%), peripheral edema (3.2%), orthostatic hypotension (1.1%), and tachycardia (3.5%). Drug-related headache and myalgia occurred in <1% of patients (0.2% and 0.4% respectively).
The following ophthalmological side effects do occur due to the disease itself but have also been reported after treatment with STROMECTOL: abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment.
Drug Interactions
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
Use in Specific Populations
Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast-feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn.
Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Clinical studies of STROMECTOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
In immunocompromised (including HIV-infected) patients being treated for intestinal strongyloidiasis, repeated courses of therapy may be required. Adequate and well-controlled clinical studies have not been conducted in such patients to determine the optimal dosing regimen.
About Merck
For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of . These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for STROMECTOL at
https://www.merck.com/product/usa/pi_circulars/s/stromectol/stromectol_pi.pdf.
Media Contact:
Patrick Ryan 973 275-
Investor Contact:
Peter Dannenbaum 908 740-
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