Men’s Health Advisor - Label change ordered for prostate drug
The U.S. Food and Drug Administration (FDA) has ordered the makers of Flomax, the most commonly prescribed drug to treat benign prostatic hyperplasia (enlarged prostate), to change the label to reflect the possibility that the drug is linked to a condition that can complicate cataract surgery. Enlarged-prostate patients often take an alpha-1 blocker–including tamsulosin, marketed as Flomax.
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However, ophthalmologists have reported cases of a condition termed intraoperative floppy iris syndrome (IFIS) during phacoemulsification cataract surgery–a procedure that uses ultrasonic vibrations to fragment the lens before removal–in patients using an alpha-1 blocker. IFIS occurred most often while people were still taking the alpha-1 blocker or had recently quit taking it, but in a few cases, the disorder was reported after the patient had been off the medication for 5 weeks to 9 months. The FDA recommended that men being considered for cataract surgery be questioned about whether they have taken Flomax or other alpha-1 blockers and that ophthalmologists be prepared for modifications to their surgical technique should IFIS occur.
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