Better start with keeping your blood serum vitamin D levels up...
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
For public safety, Merck should be busted up into smaller companies.
Um... guys...
Line 4:
“...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...”
Translation: “We don’t trust it if you go beyond the recommended dosage and if you fall under the category where it’s not suggested”.
Heck, you could say that about aspirin.
my $0.02
p
Thank you.
The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro - ScienceDirect
https://www.sciencedirect.com/science/article/pii/S0166354220302011
Great catch.
The evil ones and their word games.
BINGO!
Says the company whose stock was under $10 pre pandemic and is now over $500.
Yep, completely honest. No conflict of interest at all. Not even a whiff of duplicity. Trust them 100%. I honestly don’t know why we all make like Muslims and bow down and pray to Merck and Pfizer HQs 5 times a day.
“We do not believe”
The Covid cult strikes again.
The statement is apparently seven months old. Since then there have been more studies and more off-label use of Ivermectin for Covid. I wonder if they still hold the position expressed in this statement?
Is Ivermectin an approved countermeasures?
No.
There’s your answer.
Actually, $1,700-per-dosage Molnupiravir, an RNA chain-terminator, which works by spoofing an amino acid in the COVID virus self-repair machine. Unlike Remdesivir, it can be given orally.
Ridgeback partnered with Merck last summer to develop Molnupiravir for oral delivery to COVID patients.
In June of this year, Merck received FDA's 1.2B public committment for 1.7 million doses, with prospectus for 10 million total doses in the future.
Merck - big pharma press release
To understand the Merck statement you must parse what they said very carefully.
1. They did not do any studies themselves. They simply looked at other studies.
2. They found no clinical evidence it worked. However, the published studies that have been done to date were NOT peer reviewed clinical studies, so OF COURSE they found nothing. Real world outcomes have been great, but they are not peer reviewed clinical studies. There may be clinical studies underway, but it will take a long time for them to finish and then go through the peer review process.
Side Note: Hydroxychlorine has also been officially maligned. The highest profile “studies” attacking hydroxychlorine were published in The Lancet and The New England Journal of Medicine. Both studies have since been withdrawn. (Crickets from the media.)
3. A “concerning lack of safety data” in the majority of studies is a meaningless statement. Any retrospective study looking at actual results will have a hard time even collecting “safety data”.
Side Note: Since ivermectin has been approved and in safe widespread human use worldwide for many years, this has to be considered a deliberately misleading statement.
Side Note: It has uses with animals too, but the “horse dewormer” meme in the media is deliberate misinformation. I’m sure it’s possible to take an overdose of Ivermectin, especially if you take a dose intended for horses.
Side Note: Does anyone really think one of the major drug companies is going to dispute the official governmental and media narrative?
This drug is considered safe by the CDC and The WHO. It has one of the least number of adverse side effects. And its been around for decades. And it has been given to millions of people every year. So them calling it unsafe or untested is crap. They have an antiviral coming out. And as people pointed out. The vaccine can only be used if there is no other viable therapy. So they attack any viable therapy. It does not make Merck any money. It is too cheap.
If you don't even bother to look for it ,
then you'll never find it.
In the scientific world, that 'bother to look for it' is called research.
So, in a nutshell, they haven't even been bothered to look for the side effects of the 'jab' during an autopsy of a vaccinated recipient who died,
to determine the actual cause of death.
Also, they haven't been bothered to view the reports of the official CDC VAERS website (side effects).
Better start with keeping your blood serum vitamin D levels up...
I would bet they do, since the media is pimping everyone who endorses it to be insane.
“You aren’t horses y’all” is akin to me saying to blacks “Don’t be takin’ that shit cuz, nomsayin’?”
It’s a slap in all white faces not from the city for being deplorables.
I would like to know what studies they actually used in their analysis but couldn’t find it in their paper.
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.
they are toeing the Party woke line.
They want to get drugs approved in the future.
Don’t rock the boat
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