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Unintended intrathecal injection of vinca alkaloids can result in fatal outcomes. To prevent this, the Product Information (PI) for vincristine, vinblastine and vinorelbine products has been changed to ensure these medicines are always given intravenously and by no other route.
Vincristine sulfate, vinblastine sulfate and vinorelbine tartrate are all vinca alkaloids used alone or in combination as part of cancer therapy, as indicated in the PI for each medicine.
These products are marketed in Australia as Vincristine Sulfate Injection, DBL Vinblastine and Navelbine, and various generic brands.
Warnings that these products are for intravenous administration only are being included in the 'Dose and method of administration' section (4.2) and 'Special warnings and precautions for use' section (4.4) of the PI for these medicines. Below is a summary of the information that is being incorporated:
'Syringes should not be used for administration of vinca alkaloids. Preparation must be by dilution in small volume intravenous bags (the "minibag" technique), rather than in a syringe, to protect against accidental administration via the spinal route.
Vinca alkaloids should be prepared for intravenous use only. Fatal if given by any other route.'
Any mention of 'injecting' is being replaced by 'infusing' throughout the PI documents for all 3 medicines.
Please check the individual PI documents for specific details.
Post-marketing adverse event reports
The Institute for Safe Medication Practices (ISMP) in the US detailed multiple fatal cases where patients had been administered vinca alkaloids via the incorrect route in an article published on the US Food and Drug Administration website in 2021.
To 1 February 2022, there have been 3 cases of administration error of vinca alkaloids by the intrathecal route, including one death, reported to the TGA and included in our Database of Adverse Event Notifications (DAEN).
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.
Disclaimer
Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.
© Commonwealth of Australia 2022
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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at ADR.Reports@tga.gov.au.
Medicines Safety Update is written by staff from the Pharmacovigilance Branch.
Editor: Dr Catherine Brogan
Deputy Editor: Mr Michael Pittman
Contributors: Mr Gilbert Yeap, Ms Renae Mura