Dear Healthcare Professional Letter about the risk of appearance of an intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients treated with risperidone or paliperidone
05.10.2013
Janssen-Cilag International NV and Johnson & Johnson S.E. d.o.o., the marketing authorisation holders in the Republic of Croatia for medicinal products Xeplion 25 mg, 50 mg, 75 mg, 100 mg suspension for injection with prolonged release (paliperidone), Invega 1,5 mg, 3 mg, 6 mg, 12 mg tablets with prolonged release (paliperidone), Rispolept Consta 25 mg, 37,5 mg, 100 mg powder and solvent for suspension for injection with prolonged release for intramuscular application (risperidone), Rispolept 1 mg, 2 mg, 3 mg, 4 mg film-coated tablets (risperidone) and Rispolept 1 mg/ml solution for oral use (risperidone), have, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about the risk of appearance of an intraoperative floppy iris syndrome during cataract surgery in patients treated with risperidone paliperidone.
Summary
There is a risk of an intraoperative floppy iris syndrome (IFIS) during or after cataracta surgery in patients treated with risperidone (Rispolept, Rispolept Consta; risperidone available also as a generic in Croatia) or paliperidone (Invega) or paliperidone palmitate (Xeplion).
Taking into account that IFIS is associated with higher rate of complications of cataracta surgery, during the pre-surgery data gathering on patient’s history, it is necessary to verify the information on the current or previous use of these medicines.
Doctors performing cataract surgery should approach it with caution. If there is a suspected IFIS, the possibility exists for implementing measures in order to prevent the prolapse of the iris during the cataract surgery.
Here you may view the Dear Healthcare Professional Letter.
Halmed has not received any report to intraoperative floppy iris syndrome associated with use of risperidone or paliperidone. HALMED will continue to monitor the safe use of risperidone and paliperidone and will inform the public promptly about any new safety information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
