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This is duplicated text of a letter from Boehringer Ingelheim (Canada) Ltd.
Contact the company for a copy of any references, attachments or enclosures. |
Health Canada Endorsed Important Safety
Information
on Flomax (tamsulosin) |
October 14, 2005
| Subject: |
IMPORTANT SAFETY INFORMATION ON INTRAOPERATIVE FLOPPY IRIS SYNDROME (IFIS) |
Dear Ophthalmologist:
This communication is to inform you of a surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS)1 that has been observed during phacoemulsification cataract surgery in some patients currently or recently treated with alpha -1 blocker therapy. This variant of small pupil syndrome is characterised by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions.
Alpha -1 blocking agents are commonly used in the treatment of hypertension, and in the symptomatic management of benign prostatic hyperplasia.
FLOMAX (tamsulosin hydrochloride) is a selective alpha -1 receptor blocker indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Until there is a better understanding of the etiology of this syndrome, it is recommended that male patients being considered for cataract surgery be specifically questioned to ascertain whether they are taking FLOMAX. If so, the planned use of measures such as the utilization of iris hooks, iris dilator rings, or the use of viscoelastic devices such as Healon 5 can minimize the potential consequences of this syndrome. The benefit of discontinuation of FLOMAX prior to surgery has not yet been evaluated.
While a definitive causal relationship between IFIS and FLOMAX has not been established, Boehringer Ingelheim (Canada) Ltd. is currently working with Health Canada to amend the FLOMAX Product Monograph to include a reference to IFIS.
The identification, characterization, and management of drug-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programs. Health care professionals are asked to report any suspected adverse reactions in patients receiving FLOMAX (tamsulosin hydrochloride) directly to Boehringer Ingelheim (Canada) Ltd. or to Health Canada:
Boehringer Ingelheim (Canada) Ltd.
Drug Regulatory Affairs and Drug Safety
5180 South Service Road
Burlington, Ontario L7L 5H4
or call toll free at 1-800-263-5103 Ext. 4603
or Fax at: 905-333-4464
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel.: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries, please refer to contact information:
Bureau of Metabolism, Oncology and Reproductive Sciences
BMORS_enquiries@hc-sc.gc.ca
Tel: (613) 941-3171
Fax: (613) 941-1365
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties. |
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
Should you have any questions or require additional information regarding the use of FLOMAX (tamsulosin hydrochloride), please contact Boehringer Ingelheim (Canada) Ltd., Medical Information at 1-800-263-5103 Ext. 4633 or 905-631-4633 from 8:00 AM to 5:00 PM Monday to Friday Eastern Standard Time.
Sincerely,
original signed by
Tomasz Uscinowicz, M.D.
Vice-President, Medical
Boehringer Ingelheim (Canada) Ltd.
References:
1 Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with Tamsulosin. J Cataract Refract Surg 2005; 31:664-673.
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