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. 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. Patients treated with STROMECTOL for onchocerciasis may experience cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions.Īfter 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. STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product. SELECTED SAFETY INFORMATION FOR STROMECTOL® (ivermectin) STROMECTOL has no activity against adult Onchocerca volvulus parasites. 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. Ivermectin is approved in the United States under the brand name STROMECTOL. Indications and Usage for STROMECTOL® (ivermectin) 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. A concerning lack of safety data in the majority of studies.No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and.No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies.It is important to note that, to-date, our analysis has identified: 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. 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.
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