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 31st 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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