ERJ staff report (DS)
Lexington, Massachusetts -- US pharmaceutical company, Cubist Pharmaceuticals, Inc. has informed customers and the US-based Food & Drug Administration that some of its products, delivered by elastomeric infusion pump, have been contaminated by MBT (2-mercaptobenzothiazole). The MBT has almost certainly come from the rubber within the pump. Exposure to MBT is associated with an increased risk of death from bladder cancer.
The pumps, named ReadyMED, were made by manufactured by Cardinal Health, Inc. In this case, Cubist said in its letter, "Cubist recommends against using ReadyMED elastomeric infusion pumps with CUBICIN until this issue has been addressed."
The letter continued, "MBT is used in the manufacture of rubber as an accelerant in the vulcanization process. Human, non-occupational environmental exposure to low levels of MBT can occur through direct contact with rubber products and through consumption of water in contact with rubber plumbing products. MBT 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. Cardinal Health, Inc. has been made aware of the findings. "
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Letter to FDA from Cubist