Drug News
FDA: impurity found in Cubicin
By FDA
Apr 12, 2008 - 4:11:25 PM

Cubicin (daptomycin for injection)

Audience: Infectious disease healthcare professionals, hospital risk managers, and nursing service managers
[Posted 04/09/2008] Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed.

[April, 2008 - Letter - Cubist Pharmaceuticals, Inc.]