NPRA update on Risks associated with Systemic Corticosteroids

National Pharmaceutical Regulatory Agency (NPRA) of Malaysia release a notification on Risk of Pheochromocytoma associated with Systemic Corticosteroids.

Corticosteroids are anti-inflammatory drugs used for asthma and arthritis. Betamethasone, dexamethasone, prednisolone, methylprednisolone, triamcinolone, are types of systemic corticosteroids that are registered and currently in use in Malaysia.

Pheochromocytoma crisis is actually an emergency situation,where patients have sudden surges in catecholamine release along with haemodynamic instability that ultimately leads to organ death/dysfunction. It is basically seen in chromaffin cells in adrenal gland as it is a rare and often undiagnosed catacholamine-secreting tumour. This condition has headache, palpitations, sweating, hypertension.

The onset of pheochromocytoma crisis has been reported ranging from a few hours to a few days after systemic corticosteroid administration.

No local cases of pheochromocytoma crisis following the use of systemic corticosteroids have been reported to the NPRA.

The European Medicines Agency (EMA) and Health Canada concluded that there is a close relation between systemic betamethasone use and pheochromocytoma crisis.

NPRA Advice for health care professionals:

• Pheochromocytoma crisis is associated with significant mortality. Administer systemic corticosteroids to patients with suspected or identified pheochromocytoma only after an appropriate risk/benefit evaluation.
• Consider the diagnosis of pheochromocytoma crisis in any patient developing hypertensive crisis, cardiac failure, tachycardia, headache, and abdominal or chest pain after systemic corticosteroid administration. Prompt confirmation of the diagnosis followed by optimal management is essential to improve patient survival.
• Patients with pheochromocytoma crisis should be managed in an intensive care environment to enable appropriate monitoring and circulatory support and general supportive care. In each case, tailor specific treatment decisions to reflect which organ systems are involved.
• The role of emergency surgery without prior medical stabilisation in a pheochromocytoma crisis is controversial but is widely agreed to carry significant risks. In almost all cases, it would be appropriate to attempt surgery only after medical stabilisation has been achieved.
• Report all suspected adverse events associated with products containing systemic corticosteroids to the NPRA.

NPRA has completed a review of this safety issue and a directive had been issued for all registration holders of products containing corticosteroids for systemic use to update the local package inserts and consumer medication information leaflets to reflect this safety information.