The warning, first
The FDA requires boxed warnings on JAK inhibitors used for chronic inflammatory conditions covering an increased risk of serious heart-related events, cancer, blood clots, and death, alongside serious infections — including tuberculosis and bacterial, fungal, viral and other opportunistic infections — that have led to hospitalisation and death. Thrombosis, including deep vein thrombosis, pulmonary embolism and arterial thrombosis, some of it fatal, has occurred in patients taking these medicines for inflammatory conditions.
That is not a footnote and it is not something to discover later. It is also not the whole story, which is the next section.
Where the warning came from — and why context matters
The evidence behind the class warning came substantially from a large post-marketing safety study in rheumatoid arthritis, comparing tofacitinib against TNF blockers, which found a higher rate of malignancies excluding non-melanoma skin cancer — with higher rates of lymphoma and, among current or former smokers, lung cancer. In 2021 the FDA extended the warning across the class, to baricitinib and upadacitinib as well — while noting that those two had not been studied in a trial like the tofacitinib one, so their risks have not been evaluated to the same standard. The warning is therefore partly precautionary, which is neither a reason to dismiss it nor a reason to read it as a measured result for every drug in the class.
People with rheumatoid arthritis in that study were on average older and carried more cardiovascular risk than a typical person being considered for eczema treatment. That does not make the warning inapplicable — the FDA applied it to the class deliberately — but it does mean that how much it means for you specifically depends on you specifically: your age, whether you smoke, your cardiovascular and clotting history, your cancer history. Those are exactly the things your doctor is weighing, and they are fair to ask about out loud.
Which ones are approved for eczema
- Abrocitinib (Cibinqo) — an oral JAK inhibitor, approved for ages 12 and up.
- Upadacitinib (Rinvoq) — an oral JAK inhibitor, approved for ages 12 and up.
- Ruxolitinib cream (Opzelura) — a topical JAK, approved for ages 2 and up for mild-to-moderate disease. Being a cream does not remove it from the class: it carries the same boxed warning on its label.
Baricitinib (Olumiant) is approved for atopic dermatitis in Europe; in the US it is approved for other conditions.
The oral ones are usually taken once a day. For many people that convenience is a genuine part of the appeal — no injections, no fridge, no clinic visits.
How they differ from a biologic
This is the comparison most people actually want. A biologic like dupilumab targets a narrow part of the immune signalling and, as the AAD notes, does not suppress the immune system in the broad sense. JAK inhibitors act further upstream on a shared signalling pathway, which is why they can work quickly and across a wider range of effects — and also why the safety conversation is different. Neither fact makes one the right answer; they make them different tools. See the newer biologics and beyond creams.
Questions worth asking
- "Given my age and history, how much does the boxed warning apply to me?"
- "What monitoring comes with this — what bloods, how often, for how long?"
- "What would make us stop?"
- "Why this rather than a biologic, for me?"
- "What do I do if I get an infection while on it?"
On being frightened by a warning. Boxed warnings are written to be impossible to ignore, and they succeed. Being unsettled by one is a reasonable response, not an overreaction — and it is also not a decision. Plenty of people read this warning, discuss it properly, and go ahead with clear eyes; plenty of others choose differently. What matters is that you got to make the choice with the information in front of you rather than behind you.
Keep the record a decision like this deserves
Starting a systemic treatment is the point at which memory stops being good enough. Ollowen holds the before and after — skin, sleep, what you were on and when — so the follow-up conversation rests on a record rather than an impression.
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Sources
- U.S. Food and Drug Administration. RINVOQ (upadacitinib) prescribing information — boxed warning.
- U.S. Food and Drug Administration. CIBINQO (abrocitinib) prescribing information — boxed warning.
- American Academy of Dermatology. Atopic dermatitis: diagnosis and treatment.
- American Academy of Dermatology. Atopic dermatitis clinical guidelines.
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