Investigation of accolate and singulair for treatment of capsular contracture yields safety concerns

Abstract

At The Aesthetic Meeting 2002 of the American Society for Aesthetic Plastic Surgery, the Aesthetic Surgery Education and Research Foundation/Plastic Surgery Educational Foundation (ASERF/PSEF) Emerging Trends Task Force and Innovative Procedures Committee requested an update on zafirlukast (Accolate; AstraZeneca Pharmaceuticals, Wilmington, DE) and montelukast (Singulair; Merck & Co, West Point, PA) - what they are and how they work. These two asthma medications were reported to possibly treat and prevent capsular contracture after breast augmentation. On further analysis of postmarketing complications associated with zafirlukast based on information obtained through the Freedom of Information Act, it was discovered that between November 1, 1997, and October 31, 2002, 66 cases of hepatitis or liver failure in asthma patients occurred after a normal dose (13 of these 66 patients were taking no other medication). Two patients required liver transplants. Twenty-three deaths were reported (8 of these 23 patients were taking no other medication); 12 of these deaths followed liver failure. It should be noted that the Adverse Event Reporting System contains a disclaimer saying, "The reports have not been scientifically or otherwise verified as to a cause-and-effect relationship and cannot be used to estimate the incidence of adverse drug reactions." Many physicians entered the specific code to indicate zafirlukast as the "primary suspect" in the adverse event. Merck & Co reported no postmarketing cases of hepatitis or liver failure associated with montelukast. This article summarizes the proposed logic behind using these two asthma medications for the prevention and treatment of breast implant capsular contracture.