Dear Healthcare Professional Letter on the potential risk for patients and healthcare personnel when handling broken/cracked Velcade vials
31.07.2014
Johnson&Johnson S.E. d.o.o. has in collaboration with the Agency for Medicinal Products and Medical devices (HALMED) sent a letter to healthcare professionals on the potential risk for patientrs and healthcare personnel on the potential risk for patients and healthcare personnel handling with broken/cracked Velcade 1 mg and 3,5 mg vials during use of the product.
Summary
One complaint of broken/cracked vials was received from Germany while another was received from the USA. Complaints refer to batches that have never been placed on the Croatian market.
Due to these complaints, a detailed investigation covering the entire supply chain has been performed. No abnormalities or malfunctioning was observed which could result into cracked or broken vials. No systemic root cause has been identified which could explain the found cracks. As well, a review of the Company’s adverse event surveillance system did not reveal any previous case of cracked/broken vials and did not indicate any evidence of changes in the safety profile of Velcade as a result of these cracked/broken vial incidents.
This letter is therefore sent on the caution assumption to provide information to healthcare professionals on the potential risk associated with handling of cracked/broken vials including failure of sterility, glass particulates in the vial and accidental exposure of the personnel handling the vials. healthcare professionals are reminded with this letter to take the necessary actions when dispensing/preparing Velcade injection.
HALMED has not received any suspected quality defect report or adverse reaction to Velcade that could refer to broken/cracked Velcade vials. HALMED will continue to closely monitor the safe use of this medicine and will inform the public promptly about any new information.
Here you may viet the Dear Healthcare professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
