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:
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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 . 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-
Onchocerciasis (river blindness) ranks among the leading causes of visual impairment and blindness in Africa. The infection is caused by the filarial nematode, Onchocerca volvulus, transmitted from man to man by the man-biting simuliid or blackflies which breed in fast-flowing water.
An estimated 123 million people are exposed and about 18 million in the world suffer a grave burden imposed by the disease.1
With the availability of ivermectin (MECTIZAN®), a safe and effective microfilaricide, suitable for large-scale treatment, active community participation in ivermectin delivery became crucial. The microfilaricide needs to be given at least once per year to affected populations, and continued for more than fifteen years.
The Onchocerciasis Control Programme (OCP) and the African Programme for Onchocerciasis Control (APOC) sought for a community-based mechanism which could be integrated into and sustained by national health systems.
If you want to learn more, please visit our website Ivermectin Suppliers.
Following the findings of a multi-country study,2 APOC adopted the Community-Directed Treatment with Ivermectin (CDTI) approach with sustainable features as its principal control strategy.
This approach is an evolution from community-based delivery strategies. It promotes active community participation as an integral part of ivermectin distribution, to improve access to the drug and a sense of community ownership of the project. The communities plan their own distribution systems. They make decisions on who should distribute the drug, the method (house-to-house, central location) and place (chief's compound, school, church) of distribution. Communities collect ivermectin from a collection point if not located far from them and decide when to distribute ivermectin.
Ivermectin distributors are members of the community chosen by the community through a democratic process and trained to distribute ivermectin&#;which is considered safe enough for trained non-health personnel to handle. By , 26,821 community-directed distributors (CDDs) had distributed ivermectin to their communities in 16 countries in the OCP and APOC areas.
During health education sessions, communities are informed about the detailed tasks of a distributor. However, they are left to decide on selection and provision of incentives (if agreed) to distributors.
Different communities have varying criteria for the selection of CDDs. Generally, cultural, structural and political influences and the tasks given to the distributor, provided by the programme facilitation team during health education of the community, affect community criteria for the selection of CDDs. For example, it has been shown that including females in the facilitation team when approaching community leaders can influence community decisions to select females as distributors. Whilst community criteria may vary, available data suggest that some attributes are common to distributors. These attributes include honesty, good conduct, integrity, literacy and trustworthiness.2,3
Open in a new tabThe black biting fly
Photo: Ian Murdoch
The tasks include:
conducting a census to determine the number of ivermectin tablets required for the next distribution.
distribution of the correct dosage of drugs to eligible members based on height measurement with measuring sticks (photograph) and exclusion of those not eligible.
record-keeping.
keeping an inventory of ivermectin used, lost and unused.
referring cases of severe adverse reactions to the nearest health facilities.
To be able to carry out these tasks CDDs are trained and re-trained every year, or every two years, by members of the National Onchocerciasis Task Force (NOTF). The NOTF is a partnership between Non-Governmental Development Organisations (NGDOs) and the Ministry of Health responsible for installation of sustainable ivermectin delivery systems.
Open in a new tabDistribution of ivermectin
Photo: Pak Sang Lee
In the Table, the occupations of ivermectin distributors in 22 communities are presented. The primary occupation of 52% of the distributors is farming. Individuals with other types of occupation are selected. As shown in the Table, a community in Country A selected a policeman and a soldier to distribute ivermectin to members resident in areas inaccessible to civilians due to social unrest.
Because CDDs are required to record treatment in a notebook or register, communities select literate members (persons who can write). The current challenge to field staff is the high turnover of literate and young CDDs (e.g., students) whose aim is to secure better jobs in urban centres.
The community decides on the number of distributors and is free to change a distributor or increase the number. The number per community varies but on average 2&#;3 persons are selected. In , 6,789 CDDs were selected by 2,459 communities in five APOC countries giving an average of 2.7 ivermectin distributors per village. Community participation in the selection of distributors has been shown to increase treatment coverage rates and is a useful indicator for predicting whether a project will be sustainable.4
So far, few ivermectin distributors have been females.2,3 This situation has been attributed to poor participation of women in the traditional decision-making process. Also, in cultures where women are in seclusion, distributors are predominantly males.
This is a challenge to CDTI drug distribution strategies that require ivermectin to be swallowed in the presence of a distributor. Including females as distributors will enable treatment of other women in seclusion. In cultures where women are in seclusion and there are no female CDDs, husbands have collected ivermectin for their wives. This approach may contribute to proxy reporting and lead to inconsistencies in treatment figures reported at different levels.
Constraints influencing the tasks of ivermectin distributors have been identified as:
delays in the delivery of ivermectin from port to the community.
follow-up and treating members of the community who were absent during the period of mass treatment (absentees) and refusals.
the house-to-house mode of distribution.
complex record-keeping demands, which affect the schedule and work load of the distributor resulting, in some instances, to high attrition (fall out) rate among distributors.
Ivermectin needs to be distributed for more than 15 years. Therefore, community incentives to CDDs is a more sustainable option than incentives from external sources. It may be practically difficult, but communities have provided incentives when members understood:
they are in partnership.
the role of each partner in the delivery of ivermectin.
the monetary value of the contributions of other partners (Merck, MOH, NGDOs) to bring ivermectin to them.
that community contribution, as partners, includes support (in &#;kind&#;, cash) to distributors.
Ivermectin: a safe and effective microfilaricide
Text: Pak Sang Lee
Open in a new tabMeasuring height before providing the correct dose of ivermectin
Photo: WHO/TDR/Crump
Though the selection of distributors should be decided by the entire community, the decision-making processes that may exist in a given community prior to commencement of a control programme, has resulted in village leaders in some communities selecting themselves or relatives as distributors.
Occupations of CDDs Country A Country B Total Farmers 12 10 22 Teachers 8 1 9 Students 4 - 4 Other (Policeman + Soldier) 2 - 2 Artisan - 3 3 Civil Servants - 2 2 Open in a new tabI wish to thank Dr K Y Dadzie, Director, and Dr A Seketeli, Programme Manager, APOC for their encouragement and permission to publish this article and for use of the data. I am most obliged to the APOC and OCP countries where Community-Directed Treatment with Ivermectin (CDTI) programmes are in place.
1.
World Health Organization. Geneva: WHO; a. Twenty Years of Onchocerciasis Control. Review of the Work on the Onchocerciasis Control Programme in West Africa from to . [Google Scholar]2.
World Health Organization. . Community Directed Treatment with Ivermectin. Report of the Multi-Country Study. Document TDR/AFR/RP/96.1, Geneva: WHO. [Google Scholar]3.
African Programme for Onchocerciasis Control. Report of Independent Monitoring of Community-Directed Treatment with Ivermectin in APOC countries. .4.
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Katabarwa MN, Mutabazi D. The selection and validation of indicators for monitoring progress towards self-sustainment in community-directed, ivermectin-treatment programmes for onchocerciasis control in Uganda. Ann Trop Med Hyg. ;92:859&#;68. doi: 10./. [DOI] [PubMed] [Google Scholar]