EMA Pharmacovigilance unit updates on Iclusig, diacerein and acipimox

At its November 4-7 meetings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed new information on the cancer drug Iclusig (ponatinib) that suggests that side effects such as vascular occlusive events (blood clots obstructing the arteries or veins) occur at a higher rate than initially observed at the time of granting the European Union marketing authorization in July 2013.

Iclusing is from US drugmaker Ariad Pharmaceutical (Nasdaq: ARIA), which temporarily suspended the marketing and commercial distribution in the USA after a Food and Drug Administration investigation of an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking the drug (The Pharma Letters October 14 and November 1). The drug was granted European marketing approval as an orphan medicinal product for two indications of leukemia earlier this year (TPL July 2).

Conditions related to thrombosis such as myocardial infarction (heart attack) are known side effects of Iclusig and the current European Union product information mentions the risk of myocardial infarction, cerebral infarction (stroke) and related disorders. The PRAC advice is that patients and health care professionals may continue to use this medicine with increased caution in its authorized use and should monitor carefully for evidence of thromboembolism (formation of blood clots in the veins and arteries) and vascular occlusion.