This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Risperidone- or paliperidone-containing products - Intraoperative Floppy Iris Syndrome (IFIS) - For the Public
- Starting date:
- November 14, 2013
- Posting date:
- November 14, 2013
- Type of communication:
- Public Communication
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- General Public
- Identification number:
- RA-36743
This is duplicated text of a letter from Janssen Inc. Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
Public Communication - Health Canada Endorsed Important Safety Information on Risperidone- or Paliperidone-Containing Products
November 14, 2013
Subject: New safety information regarding the risk of complications during eye surgery associated with the use of RISPERDAL®, RISPERDAL® M-TAB®, RISPERDAL® CONSTA® (risperidone), INVEGA® (paliperidone) and INVEGA SUSTENNA® (paliperidone palmitate)
Janssen Inc., in consultation with Health Canada, is informing consumers about important new safety information regarding the risk of complications during eye surgery associated with the use of risperidone- or paliperidone-containing products. Doctors prescribe these products primarily for the treatment of schizophrenia. This risk applies to all patients undergoing surgery to correct cloudiness of the eye (cataract) who are taking or have taken these products, regardless of what condition their doctors were treating.
Cases of eye surgery complications, called Intraoperative Floppy Iris Syndrome (IFIS), have been reported with risperidone, but not with paliperidone. However, because risperidone and paliperidone are related drugs, patients taking either one of these products may be at risk for this complication.
- Complications during eye surgery have been reported in patients taking risperidone.
- These complications are characterized as follows: The pupil (the black circle in the middle of your eye) may not increase in size as needed; the iris (the coloured part of the eye) may become too flexible during surgery which may lead to eye damage.
- If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking or have taken risperidone or paliperidone.
Janssen provided this information to all eye doctors across Canada. Information regarding the risk of complication during eye surgery has been included in the consumer information document. For more information, patients should consult their health care professional. Patients should NOT discontinue their medication without consulting their physician or pharmacist first.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Any cases of complications during eye surgery or other serious or unexpected adverse reactions in patients receiving RISPERDAL®, RISPERDAL M-TAB®, RISPERDAL CONSTA®, INVEGA® and INVEGA SUSTENNA® should be reported to Janssen Inc. or Health Canada.
Drug Safety Department
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Or call toll free at 1-866-825-7122
Or email to dsscan@joica.jnj.com
Or fax to 1-866-767-5865
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
-
Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738