SAT-628 - Fixed Drug Eruption Following Dapagliflozin Initiation: A Rare Cutaneous Adverse Reaction to an SGLT2 Inhibitor

Background

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are widely prescribed for type 2 diabetes mellitus due to their glycemic and cardiorenal benefits. While genitourinary infections are well recognized adverse effects, emerging evidence indicates that this drug class may also be associated with underrecognized cutaneous adverse drug reactions (CARDs), including immune-mediated eruptions such as fixed drug eruption (FDE).

Clinical Case

A 63-year-old man with poorly controlled T2DM was evaluated for an acute, diffuse pruritic rash following recent initiation of dapagliflozin, 10 mg daily. His baseline diabetes regimen included metformin and glipizide.

Approximately eight days after starting dapagliflozin, the patient developed intense generalized pruritus followed by a widespread rash involving the neck, trunk, and extremities, with relative sparing of the palms and soles and no mucosal involvement. He had no fever, facial edema, or lymphadenopathy. He denied recent infections, other new medications, or travel.

Physical examination revealed multiple oval, well-demarcated hyperpigmented plaques scattered over the posterior neck, trunk, and extremities. Lesions were violaceous with overlying fine scale and surrounding erythema. No vesicles, bullae, skin sloughing, or positive Nikolsky sign were observed.

Laboratory evaluation demonstrated HbA1c >14%, creatinine 0.79 mg/dL (0.7–1.2), alkaline phosphatase 91 U/L (40–150), AST 18 U/L (0–55), ALT 20 U/L (5–34), WBC 4.6 K/µL (4.0–11.0), eosinophils 6.9% (0–5%), hemoglobin 14.5 g/dL (14.0–18.0), and platelets 307 K/µL (140–400). Testing for HIV, hepatitis C antibody, and syphilis were negative.

Given the temporal association with dapagliflozin initiation, characteristic well-demarcated violaceous hyperpigmented plaques, and absence of systemic symptoms or significant laboratory abnormalities, a drug-induced cutaneous reaction most consistent with FDE was suspected. Alternative diagnoses, including maculopapular drug eruption, DRESS syndrome, and Sweet syndrome, were considered but deemed less likely.

Dapagliflozin was discontinued. The patient was transitioned to an insulin-based regimen and treated with a short course of corticosteroids. On follow-up two weeks after drug discontinuation, there was resolution of pruritus with gradual improvement of post-inflammatory hyperpigmentation.

Conclusion

This case highlights a rare but clinically relevant CARD associated with dapagliflozin, most consistent with FDE. SGLT2 inhibitor-related skin reactions may occur early after treatment initiation and often lack systemic involvement. Endocrinologists should maintain a high index of suspicion for new-onset, well-demarcated skin lesions following SGLT2 inhibitor initiation, as prompt drug discontinuation can lead to rapid symptom resolution and support timely, accurate diagnosis.

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