Quote:
Is ivermectin safe?
Ivermectin is one of the safest medications known to man. It is safer than aspirin.
It has been taken over 7 billion times in over 30 countries.
Its inventors won a Nobel Prize for its efficacy and safety in 2015.
There have been many studies confirming its safety. Merck Pharmaceuticals (the then patent holders) published a study confirming it safe at 10 times the recommended dose.
An in-depth safety report based on the assessment of over 500 peer-reviewed articles on reported adverse events temporally associated with ivermectin treatment shows that the adverse effects of ivermectin used to be infrequent (< 2-5% of treated patients) and mild to moderate. They mainly consisted of dizziness, tremor, tingling and sleepiness; fever, fatigue and headache; nausea, abdominal pain and diarrhea; transient tachycardia and orthostatic hypotension; pruritus and rash. More severe neurological complications (e.g., seizures, confusion, encephalopathy) are possible, but rare. That ivermectin is routinely used throughout the world to treat scabies in elderly people without major safety issues is noteworthy.
Several national pharmacovigilance networks and international organizations released information or opinions ascertaining ivermectin safety in human subjects treated with parasitic diseases. Likewise, no severe adverse reactions have seemingly so far been described in relation to off-label studies or clinical trials of ivermectin as a potentialprophylactic or curative treatment of COVID-19.
Quote:
7.2 Toxicity
7.2.1 Human data
7.2.1.1 Adults
Amounts approaching the therapeutic doses in
animals (100 to 200 ðg/kg bodyweight) are not
hazardous to humans. Ingestions of large
quantities (10 to 100 times the animal
therapeutic dosage) may produce symptoms
resembling those observed in animal toxicology
studies at high toxic levels.
An adult female accidentally self-injected a
small quantity (approximately 200 ðg/kg)
subcutaneously. Twelve hours later she
experienced colicky pain with nausea but
recovered within 12 hours (MSD, 1988).
Clinical studies of oral ivermectin given in
doses from 2 to 200 ðg/kg (maximum 12 mg) have
shown a pattern of adverse experiences that
included only one serious event (transient
stupor). The remaining adverse experiences were
considered not serious and were chiefly of the
type expected based on the characteristics of
the underlying disease and the responses seen
after treatment with other microfilaricidal
drugs, except for reports of "depression" (not
psychiatrically tested) in four patients in open
studies (MSD, 1988).
7.2.1.2 Children
A 16-month-old boy weighing 15 kg ingested
approximately 100 to 130 mg of ivermectin (as an
injectable solution). Ten hours post-ingestion
he had mydriasis in one pupil, with frequent
vomiting, pallor, 35°C temperature, tachycardia,
somnolence and variable blood pressure. He
developed urticaria the following day, and had
recovered after three days (MSD, 1988).
7.2.2 Relevant animal data
Acute toxicity studies - LD50 (mg/kg) (MSD, 1988):
Oral
Mouse: Female 24.6 - 41.6; Male 11.6
Rat (Infant): Male & Female 2.3
Rat (Young Adult): Female 44.3 - 52.8; Male 42.8 -
52.8
Dermal
Rat: 660
At relatively high doses in animal toxicity studies, CNS
effects and visual disturbances have been observed.
Higher doses cause death due to respiratory depression.
Ivermectin, given to rats IV at a dose of 4 mg/kg,
produced moderate incoordination; 6 mg/kg induced a
state resembling anaesthesia which began one minute
after injection and lasted for four to five hours.
Higher doses caused death due to respiratory depression
(Hayes & Laws, 1991).
In a 14-week oral toxicity study in dogs, no treatment-
related effects were observed in animals given 0.5
mg/kg/day. Dogs given 1 and 2 mg/kg/day development
mydriasis and lost a small amount of weight. Four of
eight dogs given 2 mg/kg/day developed tremors, ataxia,
anorexia and became dehydrated (MSD, 1988).
Dogs given oral doses of ivermectin at 10 mg/kg produced
ataxia with tremor; at 40 mg/kg, death occurred due to
respiratory depression (Campbell & Benz, 1984).
Collie dogs have been shown to be more sensitive than
other dogs to the toxic effects of ivermectin.
Depression, tremors, mydriasis, ataxia, coma and death
have been seen in Collie dogs at 100 ðg/kg orally and
greater, but not at the recommended dose of the
commercial product (6 ðg/kg) (Campbell & Benz, 1984).
9.2 Chronic poisoning
9.2.1 Ingestion
Clinical experience of 50,000 patients who received a
dose of 150 ðg/kg in community-based trials undertaken
in Africa and Central America demonstrate an incidence
of 9% reporting adverse effects. The large majority of
these were of the Mazzotti-type (oedema, pruritis and
rash), and dizziness, lymphadenitis, transient
hypotension, arthralgia, myalgia, headache, and ocular
irritation resulting from the sudden death of massive
numbers of microfilariae, but in only 0.25% of patients
were these rated as severe (WHO, 1990a).
(so basically it wasn't the ivermectin, but the dead parasites in the body after ivermectin killed them that caused the side effects)
12.2 Specific preventive measures
Store in a cool place out of direct sunlight. Keep out of
reach of children.
Ivermectin is contraindicated in patients who have a history
of immediate hypersensitivity to the drug.
Rapid in-vivo killing of large numbers of microfilariae may
induce a systemic or ocular response. This reaction may
include optic neuritis, choreoretinitis, proteinuria,
pruritus, rash and oedema.
Ivermectin should not be administered to pregnant or
lactating women, or to young children, unless it is
considered that the benefits of therapy outweigh the
potential risks from the drug. At therapeutic doses,
clinical evidence to date indicates no increase in
congenital abnormalities in humans. However, in animal
studies at high maternotoxic doses foetal abnormalities have
occurred. ivermectin is excreted in breast milk.
Preliminary in vivo studies demonstrate that ivermectin can
enhance some of the pharmacological actions of diazepam.
Quote:
In some breeds of dogs such as collies, which are homozygotes for a nonsense mutation in ABCB1, and in Abcb1-knockout mice, ivermectin induces neurologic disorders that can be fatal.2,3 Few cases of neurologic disorders after ivermectin treatment have been reported in humans, and data are lacking on such a deleterious mutation in the human gene ABCB1.4
We report the case of a 13-year-old boy admitted to the pediatric intensive care unit for impaired consciousness. He had received a single oral dose of ivermectin (0.23 mg per kilogram of body weight) to prevent scabies infection 2 hours 30 minutes before the onset of impaired consciousness. His condition worsened 6 hours after he received ivermectin, with persistent neurologic signs, including coma, ataxia, pyramidal signs, and binocular diplopia, as well as abdominal pain and vomiting. He was monitored for 48 hours; during this period, he had a fluctuating Glasgow score and normal results on paraclinical tests. He fully recovered after 48 hours (see the Supplementary Data 1 section in the Supplementary Appendix, available with the full text of this letter at NEJM.org).
Whats really interesting though is
Quote:
VigiAccess was launched by the World Health Organization (WHO) in 2015 to provide public access to information in VigiBase, the WHO global database of reported potential side effects of medicinal products. Side effects – known technically as adverse drug reactions (ADRs) and adverse events following immunization (AEFIs) – are reported by national pharmacovigilance centres or national drug regulatory authorities that are members of the WHO Programme for International Drug Monitoring (PIDM). WHO PIDM was created in 1968 to ensure the safer and more effective use of medicinal products.
VigiAccess do a search for:
-Ivermectin you will find Total number of records retrieved: 5657 adverse events since 1992
-hydroxychloroquine Total number of records retrieved: 32329 adverse events since 1968
-COVID-19 vaccines Total number of records retrieved: 1886009 mainly since 2021 but interestingly they have its use listed since 2014
of listed in the Reproductive system and breast disorders category for the covid vaccines, the number is 59442