Label Changes for:

Cutivate (fluticasone propionate) cream

September 2010

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

 

PRECAUTIONS

  • Cutivate Cream contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin.

  • Cutivate Cream should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis

  • The following local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis, and miliaria.

Information for Patients 
  • Patients should report to their physician if they are allergic to formaldehyde
Pediatric Use:
  • Cutivate Cream contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. Cutivate Lotion should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.
  • Cutivate Cream should be discontinued if control is achieved before 4 weeks. If no improvement is seen within 2 weeks, contact a physician.
  • ...Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS

Post Marketing Experience
  • Erythema, edema/swelling, contusion, pain, sepsis, hemorrhage

  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure

     

Hide
(web2)