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Label Change for Flomax Following Report of Cataract Surgery Complications

SAN FRANCISCO, CA — November 22, 2005 — The most commonly prescribed prostate drug may complicate cataract surgery in male patients?

Two recent studies suspected this after conducting a recently published study that examined the incidence of Intraoperative Floppy Iris Syndrome (IFIS) in their cataract surgery practices with patients using Flomax or similar medications.

“Flomax does not affect vision or eye health,” said one author. “But it blocks the dilator muscle in the iris, and during cataract surgery, the pupil needs to be dilated.”

Following the announcement of their findings, ophthalmologists were asked to track the incidence of IFIS in cataract patients on Flomax and other prostate drugs, and send reports on verified cases to the Federal Drug Administration. The FDA responded to the doctors concerns and approved a label change for the drugs that reads “The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique.”

The Academy has notified its members of the FDA label change regarding the Flomax/IFIS link, and recommended that they thoroughly question their male cataract patients about prostate medications prior to surgery. Other prostate drugs in this class include Hytrin, Cardura, and Uroxatral.

In addition to having a pupil that dilates poorly, a patient with IFIS will have an iris that behaves erratically during cataract surgery. It will tend to be floppy and the pupil may suddenly constrict during the middle of surgery. This increases the risk of having surgical complications.

The two new studies suggest that cataract surgeons inquire specifically about prior use of Flomax as IFIS can occur several years after the drug has been discontinued.

“The persistence of IFIS long after the discontinuation of Flomax suggests a semi-permanent loss of iris dilator muscle tone,” one author said in his paper.

The author continues to say that it is not necessary to stop the use of Flomax, but patients should inform their ophthalmologist if they are taking the drug, or any type of prostate medication prior to having eye surgery.

“Flomax is an excellent drug for treating the symptoms of an enlarged prostate, and patients taking it should not worry, however, prior to cataract surgery, they absolutely need to inform their eye surgeon if they are, or have taken prostate drugs.”

“Being forewarned that the patient is taking Flomax allows the eye surgeon to anticipate the need for special measures during surgery,” he added.

SOURCE: The American Academy of Ophthalmology