Warnings NephroTOX 2026

Pegylated liposomal doxorubicin

Risk of renal-limited thrombotic microangiopathy

Europe. The PRAC has requested MAHs to amend the product information and package leaflet for pegylated liposomal doxorubicin (Caelyx®) to include renal-limited thrombotic microangiopathy (clogging of very small blood vessels in the kidneys) as an adverse effect.

Pegylated liposomal doxorubicin is indicated for treating metastatic breast cancer (with high cardiac risk), advanced ovarian cancer (post-first-line platinum failure), progressive multiple myeloma (in combination with bortezomib), and AIDS-related Kaposi’s sarcoma.

This recommendation follows a review of the case reports in EudraVigilance and the literature, including the cumulative review submitted by the MAH/s.

Reference:

PRAC recommendations on signals, EMA, 12-15 January 2026 (link to the source within www.ema.europa.eu)

Zoledronic acid

Use in elderly patients and risk of adverse reactions

New Zealand. Medsafe has issued a clinical reminder regarding the use of zoledronic acid in elderly patients, highlighting the increased risk of post-dose systemic reactions and renal impairment in this demographic.

Zoledronic acid is a bisphosphonate used for treating osteoporosis and Paget’s disease. In the elderly, it is often preferred due to its once-yearly intravenous administration, which overcomes adherence issues associated with oral bisphosphonates.

Data indicates that elderly patients (aged 65 and over) may be more susceptible to acute phase reactions, such as fever, myalgia, and arthralgia, typically occurring within three days of infusion. Furthermore, age-related declines in renal function increase the risk of nephrotoxicity, especially if the patient is dehydrated or taking concomitant nephrotoxic medications.

Health-care professionals should assess renal function (creatinine clearance) before each dose. Patients must be adequately hydrated prior to and after administration. Paracetamol or ibuprofen administered shortly after infusion may reduce the incidence of acute phase reactions.

Reference:

Prescriber update, Medsafe, 1 March 2026 (link to the source within www.medsafe.govt.nz)

WHO Pharmaceuticals Newsletter No. 1, 2026