IVERMECTIN/FLUVOXAMINE PRESCRIPTION REQUESTS ONLY:
PLEASE CHECK that you acknowledge and understand the WARNINGS BELOW.
PURPOSE OF INFORMED CONSENT
In order for you to be treated with ivermectin and/or fluvoxamine, you must sign this form to show that you agree to this off-label use and that you have been informed of the benefits and risks of taking such medication for off-label use, as well as the benefits and risks of declining or refusing such off-label use. You have the right to refuse to take ivermectin and/or fluvoxamine for any reason. The evidence at this time is not clear as to whether ivermectin and/or fluvoxamine will be beneficial for COVID-19 treatment or Long Haul treatment; your condition may deteriorate.
Off-label use of a drug is defined as the use of a drug to treat a condition, or target symptom(s), even though the drug is not specifically approved to do so by the US Food and Drug Administration (FDA).
Off-label use of ivermectin and/or fluvoxamine includes the use of ivermectin and/or fluvoxamine as a treatment for any viral infection or post-viral infection
BACKGROUND
Ivermectin in tablet form is approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) and is approved by the FDA for the treatment of obsessive/compulsive disorder and other conditions including depression.
According to the Lancet article Volume 10, Issue 1, E42-E51, January 1, 2022, Fluvoxamine among high-risk patients was shown to decrease hospitalization when prescribed in early treatment. Hospitalization was defined as seen in an emergency setting or admitted to a hospital. Please be advised that there are drug-to-drug interactions that may preclude you as a candidate to receive this medication. This can be found at https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext
However, there is the possibility that these medications may be of NO direct medical benefit to you. Your condition may get worse.
POSSIBLE RISKS AND KNOWN SIDE EFFECTS
It is possible that the medication prescribed may not improve your symptoms and not shorten the duration nor severity of the illness. Without limitation, it is possible that the medication will unexpectedly interfere with your ability to improve, hastens damage to the lungs or other organs, and shortens your life.
Please be advised that not all risks and side effects in the context of COVID-19 are known. In fact, as of February 11, 2021, the National Institute of Health (NIH) still notes that due to insufficient evidence, the NIH cannot recommend either for or against the use of ivermectin for the treatment of COVID-19.
I understand that Ivermectin has been approved by the FDA as a safe and effective antiparasitic medication since 1988. Since then, over 200 million people around the world use it 1-2 times a year as part of parasite treatment and disease prevention. In rare cases, ivermectin may cause pruritus, conjunctivitis, arthralgia, myalgia (including abdominal myalgia), fever, edema, nausea, vomiting, diarrhea, lymphadenopathy, orthostatic hypotension, tachycardia, asthenia, rash and headaches.
I understand that fluvoxamine can cause but is not limited to: headache, nausea, diarrhea, increased sweating, feeling nervous, restlessness, fatigue and insomnia.
I understand that fluvoxamine is contraindicated in those with a history of suicide attempt, liver problems, seizures, low sodium, peptic ulcer disease, bleeding problems, current use of another SSRI, stimulants, and a family or personal history of glaucoma.
I understand that although this is rare, fluvoxamine can cause prolonged QT intervals which may lead to a serious cardiac event even death.
I understand that I have reported my complete medical history to the practitioner. I acknowledge that failure to do so could cause serious harm to me.
ALTERNATIVES
At of December 11, 2021, the only FDA approved medication for use towards COVID-19 treatment is Veklury (Remdesivir), an antiviral drug approved for use in adults and pediatric patients [12 years of age and older and weighing at least 40 kilograms (about 88 pounds)] for the treatment of COVID-19 that requires hospitalization.
Of course, the FDA notes that the most effective ways to limit the spread of COVID-19 include getting a COVID-19 vaccine when it is available to you and following current CDC guidance.