The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety alert on the possible risk for posterior reversible encephalopathy syndrome (PRES) with ponatinib (Iclusig).
Postmarketing cases of PRES have been reported in patients receiving ponatinib and the risk could be as high as one in 100 people taking the medicine, the agency says.
A routine European Union (EU) review has identified 5 cases of PRES in patients receiving ponatinib, 2 of which were confirmed on MRI. Two cases showed a positive de-challenge effect after ponatinib's withdrawal. In both cases, signs and symptoms of PRES did not reappear when ponatinib was restarted at a lower dose.
Risk for PRES has been added as an uncommon adverse event associated with ponatinib in the Summary of Product Characteristics and Patient Information Leaflet.
The MHRA says no UK Yellow Card reports have been received for PRES association with ponatinib treatment, but it points out that the use of the product in the UK is low and continued vigilance is recommended.
Current advice for health care professionals is to advise patients to contact their health care professional immediately if they develop sudden-onset severe headache, confusion, seizures or vision changes. Treatment should be interrupted if PRES is confirmed and should resume only once the event is resolved and if the benefit of continued treatment outweighs the risk for PRES.
