Staying informed about Health Canada advisories is essential for healthcare professionals, ensuring optimal patient safety and compliance with updated regulations. Below, we highlight five crucial Health Canada advisories from February that physicians and pharmacists need to be aware of.
1. CAR-T Therapies and the Risk of Secondary T-Cell Malignancy
Health Canada has identified a potential link between chimeric antigen receptor T-cell (CAR-T) therapies and secondary T-cell malignancies. These therapies, used in the treatment of blood cancers, may lead to new cancer formations in T-cells post-treatment. Affected CAR-T therapies include:
- Breyanzi (lisocabtagene maraleucel)
- Carvykti (ciltacabtagene autoleucel)
- Kymriah (tisagenlecleucel)
- Tecartus (brexucabtagene autoleucel)
- Yescarta (axicabtagene ciloleucel)
The product monographs for these therapies are being updated with a recommendation for lifelong patient monitoring to detect secondary malignancies early.
2. Cyclosporine and Hearing Impairment
A safety review of systemic cyclosporine (Sandimmune IV, Neoral, generics) found no conclusive evidence linking its use to hearing impairment. Despite a recent European Medicines Agency labeling update, Health Canada determined that no modifications to Canadian cyclosporine product monographs are necessary at this time. Nevertheless, ongoing monitoring of cyclosporine safety continues.
3. Dasatinib and Delayed Growth in Children
A review of dasatinib (Sprycel, generics) uncovered a possible connection between the drug and delayed growth in children. Dasatinib, a BCR-ABL tyrosine kinase inhibitor, is approved in Canada for treating adult leukemia but has been prescribed off-label for children (approximately 600 prescriptions since 2018). While the data is not definitive, Health Canada has deemed it sufficient to warrant an update to product monographs for all dasatinib-containing medications.
4. Ilaris and the Risk of DRESS
Health Canada has identified a link between Ilaris (canakinumab) and drug reaction with eosinophilia and systemic symptoms (DRESS). This severe allergic reaction can cause rash, fever, elevated white blood cell count, and multi-organ injury, particularly in patients treated for systemic juvenile idiopathic arthritis. The Canadian product monograph for Ilaris is being updated to reflect this serious risk.
5. Statins and the Risk of Myasthenia Gravis
A review of statin use (HMG-CoA reductase inhibitors) found a possible association with myasthenia gravis, including ocular myasthenia, a neuromuscular condition that weakens voluntary muscles, particularly those controlling eye movement and eyelids. This class-wide effect applies to all marketed statins:
- Atorvastatin
- Fluvastatin
- Lovastatin
- Pravastatin
- Rosuvastatin
- Simvastatin
The Canadian product monographs for statin products are being updated to reflect this newly identified risk.
Final Thoughts
These Health Canada advisories reinforce the importance of continuous monitoring and vigilance in prescribing and dispensing medications. Physicians and pharmacists should ensure that patients receiving these treatments are well-informed of the potential risks and are monitored appropriately. Staying up to date with drug safety updates is crucial for enhancing patient care and minimizing adverse effects.