Safety advice on particular drugs or classes of drugs
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| Singapore: Risk of Intraocular Floppy Iris Syndrome (IFIS) with risperidone or paliperidone in patients undergoing cataract surgery |
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HSA has alerted healthcare professionals to the risk of intraoperative floppy iris syndrome (IFIS) observed during cataract surgery in patients treated with risperidone or paliperidone. IFIS has been observed during cataract surgery in patients on alpha-adrenergic antagonists and there exists a possible biological plausibility of an association between risperidone and IFIS, although such cases are very rare. The association is also extended to paliperidone since it is the active metabolite of risperidone and therefore shares similar pharmacological and safety profiles. A Dear Healthcare Professional Letter was issued to inform psychiatrists and opthalmologists of this emerging risk. The letter included advisories such as recommending cataract surgeons to ask their patient about current or prior use of risperidone or paliperidone when taking the medication history of their patients preoperatively, and to approach the surgery with caution when IFIS is suspected. Healthcare professionals are advised to document the use of alpha 1-adrenergic antagonists, including risperidone and paliperidone, when making a patient referral for cataract surgery.
Please refer to the following website of HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../risk_of_intraocular.html
In Hong Kong, there are 73 registered pharmaceutical products containing risperidone and 8 containing paliperidone. All of them are prescription-only medicines. Related news has been released by HSA on 10 January 2014 and Health Canada on 15 November 2013. A letter to inform healthcare professionals on the issue has been issued subsequent to Health Canada’s announcement.
At its meeting on February 2014, the Registration Committee has directed that the sales pack label or package insert of pharmaceutical products containing risperidone or paliperidone should include warning that IFIS has been observed during cataract surgery in patients treated with medicines with alpha 1a-adrenergic antagonist effect; and IFIS may increase the risk of eye complications during and after the operation. Current or past use of medicines with alpha 1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery. The potential benefit of stopping alpha1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy. The Drug Office of Department of Health will remain vigilant on new safety information related to risperidone and paliperidone issued by other regulatory authorities.
Ends/ Saturday, April 26, 2014
Issued at HKT 12:30
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