The U.S. Food and Drug Administration (FDA) has continued expanding the role of Dupixent (dupilumab) in treating inflammatory diseases. In recent months, the agency cleared the medication for allergic fungal rhinosinusitis (AFRS) in adults and children ages 6 and older and for chronic spontaneous urticaria (CSU) in children ages 2 to 11.
These FDA approvals add to a growing list of uses for a drug that is already prescribed to millions of patients for conditions such as eczema, asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis.
At the same time, the FDA is evaluating reports involving cutaneous T-cell lymphoma (CTCL) among some Dupixent users. The agency's review comes as researchers continue to examine a potential association between dupilumab and CTCL and as Dupixent lymphoma lawsuits begin to emerge nationwide.
The expansion of Dupixent's use and the FDA's ongoing review highlight the challenges regulators face in monitoring the long-term safety of widely prescribed medications while continuing to make treatments available to patients who may benefit.
FDA Reports and Research Involving Dupixent and CTCL
In the FDA’s October–December 2024 Potential Signals of Serious Risks/New Safety Information report, CTCL is identified as a potential safety signal associated with Dupixent. The FDA is evaluating whether regulatory action may be necessary.
The FDA routinely monitors adverse event reports submitted by healthcare providers, patients, caregivers, and drug manufacturers after medications enter the market. These reports are collected through the agency's adverse event reporting systems and can help regulators identify potential safety concerns that may not have been apparent during clinical trials.
When a pattern of reports suggests a possible risk, the FDA may identify a "potential safety signal" and conduct further evaluation. The designation doesn’t mean the agency has determined a medication causes a particular injury or disease, but it does indicate that additional investigation may be warranted.
Dupixent has also drawn regulatory attention because of a growing body of research examining a potential link between the medication and cutaneous T-cell lymphoma. A 2024 study published in the Journal of the American Academy of Dermatology analyzed nearly 20,000 patients treated with dupilumab for atopic dermatitis. Researchers found that patients taking Dupixent had a 4.59-fold increased relative risk of developing CTCL compared to patients who did not use the medication. The study also found that approximately 62% of CTCL diagnoses occurred within the first year of treatment.
While researchers continue to investigate the relationship between Dupixent and lymphoma risk, questions remain about whether the medication contributes to the development of the disease or may help uncover cases that were previously undiagnosed.
Why CTCL Is Often Mistaken for Eczema
Cutaneous T-cell lymphoma is a rare form of non-Hodgkin lymphoma that affects T-cells, a type of white blood cell involved in the immune system. In its early stages, CTCL may appear as dry, red, itchy patches of skin that closely resemble eczema or psoriasis.
Because the symptoms overlap with common inflammatory skin conditions, diagnosis can sometimes be delayed. Patients may require skin biopsies, laboratory testing, and specialist evaluation before CTCL is identified. This diagnostic challenge has received increased attention in Dupixent-related research because the medication is commonly prescribed to treat eczema.
Dupixent Lymphoma Lawsuits Continue to Develop
Questions about Dupixent's long-term safety have also led to lawsuits against the drug's manufacturers. In late 2025, Childers, Schlueter & Smith (CSS) filed Georgia's first Dupixent lawsuit on behalf of a woman who claims she developed cutaneous T-cell lymphoma after using the medication. According to the lawsuit, the manufacturers failed to adequately warn patients and healthcare providers about research, adverse event reports, and other evidence suggesting a potential connection between Dupixent and CTCL. Similar allegations are commonly seen in dangerous drug litigation when plaintiffs claim manufacturers knew or should have known about potential risks associated with a medication.
The manufacturers have denied that current evidence establishes a causal relationship between Dupixent and lymphoma and have publicly stated that their safety evaluations do not support such a conclusion.
For patients currently taking Dupixent, medical experts generally recommend discussing any concerns or unusual symptoms with a healthcare provider rather than stopping treatment without medical guidance.
While Dupixent litigation remains in its early stages, attorneys expect additional lawsuits could be filed as awareness of the research and regulatory review grows. As with many pharmaceutical cases, courts could eventually be asked to consider whether Dupixent lawsuits should be consolidated for coordinated pretrial proceedings if a significant number of cases are filed nationwide.
At Childers, Schlueter & Smith, we are actively investigating claims involving individuals diagnosed with cutaneous T-cell lymphoma after taking Dupixent. Our attorneys have extensive experience handling pharmaceutical litigation and continue to monitor developments involving Dupixent, CTCL research, and related lawsuits. If you or a loved one developed CTCL after using Dupixent, you may have legal options. You can contact CSS online, use our live chat, or call 1-800-641-0098 for a free consultation.
