Aczone Side Effects May Be Cause of Blood Disorder: Report

A new case study raises concerns about potential side effects of Aczone, warning that a 19 year-old user of the acne drug developed a rare blood disorder. 

Doctors from the University of Pittsburgh Medical Center wrote a letter to the New England Journal of Medicine recounting a case of methemoglobinemia after a teen used Aczone, a topical acne gel, on her face.

The patient came into the hospital’s emergency room with blue lips and fingers; a sign of cyanosis, or low oxygen saturation of the blood. She had taken Celexa and birth control pills, as well as Aczone on her face to treat severe acne, the doctors noted.

Aczone (dapsone, or diaminodiphenylsulfone) is a prescription topical gel for the treatment of severe acne. It is manufactured by Allergan and was approved by the FDA in 2005. Dapsone is otherwise generally given in tablet form.

Methemoglobiemia occurs when there are high levels of methemoglobin, which contains ferric iron, in the blood. This ultimately reduces the ability of red blood cells to deliver oxygen to tissues.

In a supplementary appendix (PDF), the doctors explained how the Aczone side effects may cause methemoglobiemia, and lead to the blood’s supply of oxygen getting dangerously low. However, they were unable to explain why the girl was able to absorb enough to cause a health problem, raising questions as to whether other Aczone users may be at risk.

“There is no known explanation for enhanced absorption of dapsone in this patient. She had no open wounds on her face, nor had she undergone any dermatologic procedures (such as laser epilation) that could potentially enhance dermal absorption,” the researchers noted. “Her application of the medication was as prescribed. This case highlights the potential for systemic absorption following prescribed therapeutic use of a topical dapsone-containing product.”