WEDNESDAY, Nov. 23 (HealthDay News) -- The U.S. Food and Drug Administration warned Tuesday that men taking the drug Flomax (tamsulosin) for benign prostatic hyperplasia, or those who have taken it in the past, could experience problems during cataract surgery.
Intraoperative Floppy Iris Syndrome (IFIS), an adverse event that can cause a flaccid, prolapse-prone iris, has occurred during phacoemulsification cataract surgery in some patients taking Flomax, or other alpha-1 blockers, the FDA said.
The drug's maker, Boehringer Ingelheim Pharmaceuticals, Inc., and the FDA Safety Information and Adverse Event Reporting Program, issued a "Dear Doctor" letter to inform health care professionals of revisions to the "precautions" and "adverse reactions" sections of the Flomax label.
Most problems happened in patients taking the alpha-1 blocker when IFIS occurred, but in some cases, the drug had been stopped two to 14 days before surgery, and in a few cases, five weeks to nine months before surgery, according to Boehringer Ingelheim.
Men being considered for cataract surgery should be asked specifically whether they have taken Flomax or other alpha-1 blockers, according to the FDA. "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."
More Information -- FDA
More Information -- Boehringer Ingelheim
