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Well, the good news is that hospitals are finally using another drug to treat COVID aside from the failed remdesivir . The bad news is that this drug comes with a rare FDA “black box” warning of causing blood clots and also costs a fortune. Why is it that our government trashes every cheap, safe outpatient therapeutic that has been used for decades without problems, but only approves expensive therapeutics that cause blood clots or renal failure (in the case of remdesivir)? This is the ultimate case of therapeutic nihilism.
Last November the FDA quietly gamed emergency authorization use to baricitinib, a drug used for acute rheumatoid arthritis, which is produced by Eli Lilly under the brand name Olumiant. The specific authorization is for COVID patients requiring supplemental oxygen , non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Unlike remdesivir, baricitinib is an anti-inflammatory Janus kinase (JAK) inhibitor, which helps ratchet down pro-inflammatory cytokines. As such, it’s very likely that it does have more efficacy during the inflammatory stage than the worthless remdesivir. The problem is that it comes with an FDA black box warning about causing blood clots, the very condition you are trying to treat at the critical stages of COVID illness. Here is the warning on blood clots: Thrombosis: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated. Pulmonary embolism is literally the most delicate condition intensivists must deal with when treating COVID patients in the ICU. It’s liking fighting a fire with a blowtorch!
At the beginning of the month, the FDA announced it was updating its warnings because drugs like “Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated.” However, because it has the same mechanism of action, it is suspected […]
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