Posted on 09/08/2021 8:01:58 AM PDT by SoConPubbie
KENILWORTH, N.J., Feb. 4, 2021 – 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.
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 1995. 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 2019 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 973 275-7075
Investor Contact:
Peter Dannenbaum 908 740-1037
LIES AND CONSPIRACY AND COLLUSION.
This just pisses me off.
MacIvermectin!
PLAY BAGPIPE MUSIC WHILE TAKING IT.
dr, PIERRE KORY AND THE HEALTH CARE ALLIANCE HAVE BEEN USING iVERMECTIN WITH GREAT SUCCESS FOR OVER A YEAR AND A HALF.
This article describes how Ivermectin works:
“Ivermectin docks to the SARS-CoV-2 spike receptor-binding domain attached to ACE2”
Merk has too much skin in the vaccine game and do not tell the truth.Its propaganda.
Merck = paid to LIE.
Great graph. Before seeing it, I concluded getting it to 32 ng/ml is a good goal, because when we reach that level, the body starts inactivating Vitamin D.
People take too much Vitamin D. For a long time, people in cold countries took 10 micrograms per day.
For an experiment, people took 100 micrograms per day for a few months. Their blood level was 67 ng/ml. People with 50 ng/ml have more kidney stones.
Groups at higher risk for the wuhan coronavirus have more stored iron.
You also need vitamin k2
For public safety, Merck should be busted up into smaller companies.
Get rid of patents.
I believe Molnupiravir is in stage 3 testing.
This explains in common language Intermectin and hydroxiQ. And the phase 3 drug.
Liars that push the clot shot say things like this.
Merck is listed as a partner (donor) on the CDC Foundation (yes, the CDC has it’s own 501c3) website. We are ruled over by abusive pharma and their friends. FWIW, Bill Gates is the largest donor to the CDC’s Foundation. He donates to the NIH and has an extensive history with them. He virtually owns the WORLD HEALTH ORGANIZATION; they treat him like a God.
Why do WE the PEOPLE have to give TAX MONEY to the CDC, who serves the interests of our enemies, and Eugenicists like Bill Gates?
Merck is listed as a partner (donor) on the CDC Foundation (yes, the CDC has it’s own 501c3) website. We are ruled over by abusive pharma and their friends. FWIW, Bill Gates is the largest donor to the CDC’s Foundation. He donates to the NIH and has an extensive history with them. He virtually owns the WORLD HEALTH ORGANIZATION; they treat him like a God.
Why do WE the PEOPLE have to give TAX MONEY to the CDC, who serves the interests of our enemies, and Eugenicists like Bill Gates?
DEFUND THE CDC!
Should be noted that according to FLCCC, anyone taking Ivermectin as a prevention against COVID, should take it with food...
Empty stomach listed in the Merck document is for deworming/parasites...
“I would like to know what studies they actually used in their analysis but couldn’t find it in their paper.”
The meta analyses I have read rarely list the individual studies that were included. This information is often available from the authors or in supplemental appendices available from the journal.
“There was another meta analysis of 10 studies posted here the other day, but it included several studies that had fatal flaws according to the reviewers. In fact, one was so flawed, 100 doctors signed a letter to JAMA asking them to retract it from their publication.”
Yes. My point was simply that the conclusions from published meta analyses concerning the effectiveness of ivermectin are mixed.
This is a good resource - it is a real time meta analysis of 63 studies but also discusses each study (strengths and weaknesses) https://ivmmeta.com/
Should be noted that according to FLCCC, anyone taking Ivermectin as a prevention against COVID, should take it with food
Taking it with food probably increases absorption. There is one dose for taking it with water, another with food.
“This is a good resource - it is a real time meta analysis of 63 studies but also discusses each study (strengths and weaknesses) https://ivmmeta.com/“
Very interesting; thanks.
Should be noted that according to FLCCC, anyone taking Ivermectin as a prevention against COVID, should take it with food
Taking it with food probably increases absorption. There is one dose for taking it with water, another with food.
Can you post your source for dosages...I am using FLCCC.
If take without food, Ivermectin is targeting the parasites in gut. If take with food...esp fats, Ivermectin goes thru the blood barrier and targets Covid. FLCC says to take with food, so I do..
https://covid19criticalcare.com/
I just would hate to have people taking it on empty stomach thinking they are protecting themselves from Covid when they may not be.
Regarding absorption, it is forgiving...So if absorb higher percentage, it may be OK...Can’t be stupid and ingest the entire tube...Freepers can find lots of information here on dosages.
People need to do research. I trust FLCCC with Drs. Kory and Marik.
Yet we give it away free to illiterate African villagers...
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