Buzz
Some individuals are still attempting to prevent and treat COVID-19 using ivermectin, the controversial medication often marketed as 'horse paste.' The same questionable health experts promoting this drug are also endorsing entire 'protocols' that include other drugs, some of which have alarming side effects.
One such example is the FLCCC protocol, available as a PDF handout from a website that uses medical terminology and a calming design to create the impression of professionalism. However, the treatments they suggest for COVID are largely viewed as fringe by the medical community. Earlier this month, the American Medical Association, American Pharmacists Association, and the American Society of Health System Pharmacists issued a statement strongly opposing the prescribing or use of ivermectin to prevent or treat COVID-19 outside clinical trials. The FLCCC protocol includes various dosages of ivermectin for a broad range of patients.
Dutasteride and finasteride are contraindicated in pregnancy and were previously classified in pregnancy category X, alongside thalidomide.
One of the medications falls under the same pregnancy category as thalidomide
After addressing ivermectin, iodine gargle and mouthwash, aspirin, melatonin, zinc, and vitamins, the protocol introduces 'second line agents,' starting with two anti-androgens: spironolactone and dutasteride (or finasteride).
Dutasteride and finasteride are contraindicated during pregnancy and were once classified in pregnancy category X, the same category as thalidomide. (The FDA stopped using lettered categories in 2015, but the risks remain unchanged.) Spironolactone was categorized as pregnancy category C, meaning there isn't ample data on human pregnancies, but animal studies suggest it poses risks during pregnancy and may cause birth defects. All three medications come with strong warnings for those who are pregnant or may become pregnant. To underscore the severity, the warnings on Drugs.com for dutasteride (previously in category X) include the following:
-This medication could cause fetal harm, as abnormalities in male fetal genitalia are expected due to the drug's effect on inhibiting the conversion of testosterone to dihydrotestosterone (DHT).
-Condom use is advised for male patients with female partners who are or may become pregnant, as it is unclear whether male fetuses could be harmed by exposure to the semen of a patient undergoing treatment with this drug (the risk is highest during the first 16 weeks of pregnancy).
-Patients must refrain from donating blood for at least 6 months after their final dose to prevent pregnant women from receiving this drug through blood transfusion.
-The potential for reduced male fertility cannot be ruled out.
Animal studies have shown harmful effects on male fetuses, including disruption of normal external genitalia development and feminization of genitalia. This medication is present in semen, though the amount available for vaginal absorption may be diminished due to its high protein-binding (over 96%) in human semen. In a study involving healthy men aged 18 to 52, reductions in sperm count, semen volume, and sperm motility were observed, although sperm concentration and morphology remained unaffected.
What’s particularly concerning to me is that the FLCCC protocol, circulating as a PDF, fails to provide any pregnancy warnings in its instructions for using these drugs. Several other medications in the protocol do include pregnancy-related notes: The iodine nasal spray is advised for use only for five days in pregnant patients, there’s a footnote stating the safety of ivermectin during pregnancy has not been established, and pregnancy is highlighted as a risk factor when considering antibody therapy usage.
There is a warning about avoiding anti-androgens during pregnancy, but it’s absent from the protocol sheet. Instead, it’s buried at the end of the latest version of the website’s FAQ, not in the first question addressing why certain medications were included, nor in the third question claiming that anti-androgens are 'not only for men, but also for women,' but in the sixth question, which generally covers contraindications. There, you’ll find the statement: 'Anti-androgens are contraindicated during pregnancy and breastfeeding and should not be administered to children.'
Another drug in the protocol carries a suicide warning
Other medications in the protocol also come with alarming side effects. Fluvoxamine and fluoxetine are included, but these SSRIs are typically prescribed for depression (and, as noted by the NIH, they are not approved to treat COVID or any other infection). There are numerous reasons to avoid self-prescribing an SSRI without proper medical justification, but the protocol does include a footnote that highlights one of the most important concerns:
Some individuals taking fluvoxamine may experience severe anxiety, which must be carefully monitored and managed by the prescribing doctor to prevent rare cases of escalation into suicidal or violent behavior.
Although the website advocates obtaining medications through legitimate medical channels (such as via a doctor's prescription), not many healthcare providers will support these unorthodox treatments. We've seen how people have resorted to using horse dewormer and other over-the-counter versions of ivermectin; if someone were to obtain fluvoxamine for COVID treatment, it's likely they'd use it without the oversight of a healthcare professional.
What to do if a loved one is following an online 'protocol'
If someone you care about is using ivermectin or mentions following an online protocol, please check in with them, even if you think they won’t listen. While you might not be able to stop them from taking horse paste, they need to be informed about the potential serious side effects of the medications they’re using.
I've only highlighted two of the more dangerous risks here, but every medication comes with its own list of warnings, contraindications, and possible side effects to watch out for. Certain medications shouldn’t be mixed, so if someone is already taking other prescriptions or over-the-counter drugs, it's crucial to know whether it's safe to add a new one to the regimen.
The FLCCC protocol is just one of many, and each protocol recommends a different combination of treatments alongside ivermectin. For example, a protocol from Dr. Zelenko includes antibiotics, corticosteroids, blood thinners, and other medications—drugs typically used in medicine when the benefits outweigh the risks, but they should never be taken lightly. This protocol also includes a statement in all caps urging to 'TRY TO KEEP PATIENTS OUT OF THE HOSPITAL,' which might encourage people to delay seeking proper medical care.
Talk to your loved one about exactly what they’re taking, and if they're open to it, research the side effects and warnings together. Make sure they know you care about their well-being, and keep the lines of communication open.
