Class 4 drug alert for Kyowa Kirin Bleo-Kyowa Powder Solution

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Class 4 drug alert for Kyowa Kirin Bleo-Kyowa Powder Solution

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for the Bleo-Kyowa powder over a ‘minor’ defect being reported.

The agency cites glass particles being detected in a batch of the medicine back in April 2017.

Hospitals, pharmacies and other healthcare providers are requested to take caution in using the Bleomycin Sulphate powder that acts as an anticancer chemotherapy medicine.

The medicine is used for:

Skin cancer
Thyroid cancer
Lung cancer
Bladder cancer
Hodgkin’s disease
Testicular tumours or cancer
Malignant effusions

Only one batch is reportedly affected in the medical alert: 97B210.

The packets contain 10 doses and were first distributed in November 2017, and are due to expire on 31^st August 2020. The marketing authorisation holder is conducting an investigation into the quality defect. New batches are reportedly unaffected and meet current quality requirements, and will therefore continue to be supplied to the U.K.

In the meantime, healthcare professionals are to take additional measures before using Bleo-Kyowa powders belonging to the alerted batch:

Follow the recommended steps for preparing the powder
Carefully inspect the product under a bright light
If particulate or bits of glass can be seen, the product must not be used. The vial is to be retained and quarantined from the rest of the stock. The clinician is required to inform the marketing authorisation holder that they possess a defective pack
If no particulate or bits of glass can be seen, the use of a standard 5 micron (5µm) filter needle must be used to withdraw the product from the vial before administrating it into the patient. The needle should filter out the glass particles that aren’t easily visible

Glass particles in medicine of-course carry a very clear danger for patients. Sharp edges aside, it’s a foreign material that should not be inside our bloodstream at all. If the particulates are injected into the blood stream through the vein, they may be carried to the heart and then the lungs via the pulmonary arteries, causing damage.

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The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.

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Class 4 drug alert for Kyowa Kirin Bleo-Kyowa Powder Solution

Class 4 drug alert for Kyowa Kirin Bleo-Kyowa Powder Solution

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