People are still attempting to prevent and treat COVID-19 with ivermectin, the medication that’s famously available in the form of “horse paste.” But the same groups of sketchy health experts who recommend this drug are also recommending entire “protocols” that contain other medications, including some with scary side effects.
One of these is the FLCCC protocol, available as a PDF handout from a website that uses terminology and soothing design elements that give off an air of medical professionalism. But the treatments they recommend for COVID are considered fringe in the medical community. Earlier this month, the American Medical Association, American Pharmacists Association, and the American Society of Health System Pharmacists issued a statement in which they “strongly oppose the ordering, prescribing, or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial.” The FLCCC protocol calls for ivermectin in various doses for a wide variety of patients.
One of the drugs is in the same pregnancy category as thalidomide
The FLCCC has several protocols, but the one that I’ve seen most commonly recommended in ivermectin Facebook groups is this one for prevention and what they call early outpatient treatment — in other words, what you might use if you or a loved one has gotten sick but isn’t in the hospital yet.
After ivermectin, iodine gargle and mouthwash, aspirin, melatonin, zinc, and vitamins, the protocol gets into “second line agents,” and the first of these is a pair of anti-androgens, spironolactone and dutasteride (or finasteride).
Dutasteride and finasteride are contraindicated in pregnancy and were formerly in pregnancy category X, same as thalidomide. (The FDA stopped using lettered categories in 2015, but the risks remain the same.) Spironolactone was in pregnancy category C, which means there isn’t a lot of data on human pregnancies, but based on animal studies it’s understood to be dangerous in pregnancy and to likely cause birth defects. All three drugs come with warnings for people who are pregnant or could become pregnant. To give you a sense of how serious this is, the warnings on Drugs.com for dutasteride (former category X) include these:
-This drug may cause fetal harm as abnormalities in the genitalia of male fetuses are an expected consequence of this drug’s inhibition of the conversion of testosterone to dihydrotestosterone (DHT).
-Condom use is recommended for male patients with female partners who are or may potentially be pregnant as it is not known whether a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with this drug (the risk of which is greatest during the first 16 weeks of pregnancy).
-Patients should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving this drug through blood transfusion.
-The possibility of reduced male fertility cannot be excluded.
Animal studies have revealed adverse effects in male fetuses including inhibition of normal development of external genitalia and feminization of the genitalia. This drug is secreted into semen; however, the amount of this drug available for vaginal absorption may be reduced by how highly protein-bound (greater than 96%) this drug is in human semen. In a study with healthy men aged 18 to 52, reductions in sperm count, semen volume, and sperm motility were observed; however, sperm concentration and sperm morphology were unaffected.
What’s most shocking to me is that the FLCCC protocol, which is being passed around as a PDF, does not include any kind of pregnancy warning on its instructions for using these drugs. Several other drugs in the protocol have a note about pregnancy: There’s a note that the iodine nasal spray should only be used for five days if the patient is pregnant, a footnote that the safety of ivermectin in pregnancy has not been established, and a note recommending pregnancy as one of the risk factors to use when deciding whether to use antibody therapy.
There is a note warning not to take anti-androgens during pregnancy, but it’s not on the protocol sheet at all. It’s buried at the bottom of the latest version of the website’s FAQ, not in question #1 about why certain medications were added, not in question #3 which argues that anti-androgens are “not only for men, but also for women,” but in the last question, #6, which is a general one about contraindications. That’s where you’ll find the statement “Anti-androgens are contraindicated in case of pregnancy and breastfeeding and should not be administered to children.”
Another of the drugs has a suicide warning
Other medications on the protocol also have scary side effects. Fluvoxamine and fluoxetine are on the FLCCC protocol, but these are SSRIs normally prescribed for depression (and, as the NIH notes, are not approved to treat COVID or any other infection). There are many reasons not to start dosing yourself with an SSRI without a good medical indication, but the protocol does include a footnote with one of the more important ones:
Some individuals who are prescribed fluvoxamine experience acute anxiety which needs to be carefully monitored for and treated by the prescribing clinician to prevent rare escalation to suicidal or violent behaviour.
While the website talks about getting medications through legitimate medical channels (for example, prescribed by a doctor), not many doctors will be on board with these non-standard treatments. We’ve seen how people have turned to horse dewormer and other over-the-counter sources of ivermectin; if somebody were to get their hands on fluvoxamine for COVID treatment, it’s likely that they might end up taking it without the close supervision of a medical professional.
What you can do if a loved one is following an internet “protocol”
If a loved one is taking ivermectin or if they say something about following an internet protocol, please check in with them, even if you don’t think they’ll listen to you. You might not be able to convince them not to eat horse paste, but they deserve to know that they’re taking medications that have potentially serious side effects.
I’ve only noted two of the more dangerous ones here, but every medication has a list of warnings and contraindications that should be considered, and a list of potential side effects to watch out for. Some medications should not be taken together, so if a person is already on other prescription or over-the-counter medications, it’s important to know if a new one is safe to add to the mix.
The FLCCC protocol is not the only one out there, by the way, and each protocol has a different selection of things you’re supposed to take alongside ivermectin. For example, this one from a Dr. Zelenko includes antibiotics, corticosteroids, blood thinners, and more — stuff that is often used in medicine when the benefits outweigh the risks, but that shouldn’t be taken without careful consideration. It also includes a note in all caps to “TRY TO KEEP PATIENTS OUT OF THE HOSPITAL,” which could potentially lead people to delay care.
So talk with your loved one about what exactly they’re taking, and research side effects and warnings together if they’re open to having a conversation. Make clear that you care about their health, and be sure to stay in touch.