By: Keith Donovan and Matthew Fogg
The FDA has expanded approval of Dupixent® (dupilumab) for children aged six and older with allergic fungal rhinosinusitis (AFRS). It is the first FDA approval for this condition. This follows a trend in the manufacturer targeting pediatric patients diagnosed with Eczema (six months old), Asthma (six years old), Eosinophilic Esophagitis (one year old), Chronic Spontaneous Urticaria (12 years old), and Chronic Rhinosinusitis with Nasal Polyps (12 years old)
For families, this is more than another approval announcement. It means more children may now be prescribed Dupixent. It also means more parents may need clear information about the cutaneous T-cell lymphoma (CTCL) concerns being raised in Dupixent legal claims.
The core allegations of Dupxient claims are not that it is unsafe for every patient. Rather, the allegations are that manufacturers failed to adequately warn doctors and families about the risk of CTCL and the danger that early lymphoma symptoms could be mistaken for eczema or another inflammatory skin condition.
Dupixent® (dupilumab) is a prescription injectable medication developed by Sanofi and Regeneron and first approved by the FDA in 2017. It has come under scrutiny in connection with cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma, that can closely resemble eczema in its early stages. Recent publications have raised concern about an association between dupilumab use and later CTCL diagnosis, while also noting an important competing explanation: some patients may have had undiagnosed CTCL before starting treatment.
For children and families, that concern is especially difficult. A child may be treated for what appears to be eczema, only for the symptoms not to improve, to change in appearance, or to later be identified as CTCL.
The FDA new approval covers adults and pediatric patients age six and older with AFRS who have a history of sinonasal surgery. The agency also said Dupixent’s effectiveness and safety were evaluated in a 52-week study of adult and pediatric participants age six and older.
Broader approval means broader pediatric exposure. As more children are prescribed Dupixent for more conditions, more families may face the risks alleged in CTCL litigation, including delayed diagnosis, missed warning signs, and lost opportunities for closer monitoring, or earlier testing.
CTCL can resemble eczema in its early stages, which can make warning signs harder to recognize, especially in a child already being treated for a skin condition. Parents should pay close attention to symptoms that seem unusual and speak up if a rash, lesion, or flare starts to look, spread, or behave differently than what their child typically experiences.
Consult a dermatologist promptly if anything looks unusual or feels different from a typical flare. Several red flags may deserve closer attention.
Families may want to ask more questions if a child has:
Skin patches that become thicker, more rigid, or more leathery than expected
Persistent plaques or nodules that do not respond to treatment
Isolated areas that do not clear even when other symptoms improve
A rash that worsens, spreads, or changes in appearance
Swollen lymph nodes, especially in the neck, armpits, or groin
Night sweats, fatigue, weight changes, or other unexplained symptoms
These symptoms do not automatically mean cancer. But they are often cited as reasons a biopsy or further testing should be considered, particularly when symptoms are persistent or treatment-resistant.
If a child on Dupixent is not improving as expected, parents should ask whether the diagnosis should be revisited. They should also ask the child’s dermatologist whether a biopsy should be considered. A biopsy is a routine procedure and remains the most reliable way to rule out CTCL.
Families should also consider gathering:
Prescription records showing when Dupixent was started
Photographs showing changes in the skin over time
Notes from doctor visits about persistent rashes or treatment failure
Records showing when CTCL was diagnosed and what symptoms were present beforehand
This kind of documentation can help families understand what happened and when. It can also be important if they later seek legal review.
Most importantly, do not stop taking Dupixent without medical guidance. Abruptly stopping a medication can have severe consequences.
If your child took Dupixent and was later diagnosed with CTCL, Morris James can review the treatment history, symptom progression, and diagnosis timeline with you free of charge and with no obligation.
Contact us at 302.655.2599 or online to discuss your situation and learn whether you may have a claim.
CTCL can resemble eczema in its early stages, which can make warning signs harder to recognize, especially in a child already being treated for a skin condition. Parents should pay close attention to symptoms that seem unusual and speak up if a rash, lesion, or flare starts to look, spread, or behave differently than what their child typically experiences.
