FDA Receives Reports Linking Type 2 Diabetes Drug With Serious Skin Diseases

The U.S. Food and Drug Administration (FDA) has received reports linking certain serious and painful skin diseases to Dipeptidyl peptidase (DPP-4) inhibitors, including:

  • Bullous Pemphigoid
  • Erythema multiforme
  • Drug eruption
  • Stevens-Johnson syndrome
  • Eczema
  • Oculomucocutaneous syndrome

The onset of these reactions typically occurred within the first three months of the initiation of treatment.   Sometimes they occur after the first dose.

Despite numerous reports of serious and painful skin diseases, the FDA has only required a label change to include the risk of Bullous Pemphigoid. Each of the individuals reported having Bullous Pemphigoid resulted in a serious outcome, with half requiring hospitalization and one resulting in death, according to the FDA.

Symptoms of Bullous Pemphigoid

Bullous Pemphigoid is a rare skin disorder that causes rashes and blistering. Symptoms of the condition include:

  • Blistering on the arms, legs, abdomen, and mucous membranes of the eyes, nose, mouth, and genitals.
  • Red rash (develops before blistering).
  • Large, fluid-filled blisters (usually clear, may contain blood).
  • Skin around blisters appears normal, slightly red, or dark.
  • Sensitive and painful ruptured blisters.
  • Hives and itching.

A physician or dermatologist diagnoses Pemphigoid by performing a biopsy of the affected area.

What are DPP-4 Inhibitors and How Do They Work?

DPP-4 inhibitors are medications that, when used in combination with diet and exercise, can lower blood sugar in adults suffering from type 2 diabetes. The FDA approved the first DPP-4 inhibitor, Januvia, in 2006.

DPP-4 inhibitors work in an entirely different way than other diabetes medications, which inhibit an enzyme in the gut that breaks down the hormones that help lower blood glucose. DPP-4 inhibitors inactivate hormones called incretins in the gut, promoting higher levels of incretins to keep blood glucose in the normal range, particularly after meals.