Direct healthcare professional communication on the increased rate of relapses of haematological malignancies and mortality in Hematopoietic Stem Cell Transplantation (HSCT) patients treated with azithromycin
02.05.2018
Belupo lijekovi i kozmetika, Jadran - Galenski Laboratorij d.d., Krka-Farma d.o.o., PharmaS d.o.o., Pliva Hrvatska d.o.o. and Sandoz d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), have informed healthcare professionals on the increased rate of relapses of haematological malignancies and mortality in Hematopoietic Stem Cell Transplantation (HSCT) patients treated with azithromycin.
This was observed in the ALLOZITHRO clinical trial which investigated long-term azithromycin administration to prevent bronchiolitis obliterans syndrome (BOS) in patients who underwent allogenic HSCT for haematological malignancy. The trial was terminated early after an increased risk of relapses was seen in patients taking azithromycin compared with placebo.
Although it is not clear how azithromycin could have contributed to the observed higher rate of haematological relapses, in the study, it was concluded that long term azithromycin exposure following HSCT may include risks which exceed the anticipated benefits.
Azithromycin is not authorised for prophylaxis of BOS in patients undergoing HSCT. Equally, analysis of all relevant available data do not suggest that this risk applies to other patient populations or to approved indications in short and long term use.
The direct healthcare professional communication is available here.
Healthcare professionals are being reminded that they should report any suspected adverse reaction, as well as quality defect to HALMED. Patients who have developed an adverse reaction to a medicinal product may also report it directly to HALMED. HALMED recommends that patients contact their doctor or pharmacist regarding any adverse reaction they notice.
