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U.S. Department of Health and Human Services

Safety

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Flomax (tamsulosin HCl)

Audience: Ophthalmologists, Urologists, and other healthcare professionals

[Posted 11/22/2005] Boehringer Ingelheim and FDA notified healthcare professionals of revisions to PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for Flomax, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers including Flomax. Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken Flomax or other alpha-1 blockers. If so, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.

[November 2005 - Letter - Boehringer Ingelheim]
[October 2005 - Label - Boehringer Ingelheim]