For Immediate Release
November 14, 2005

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FDA APPROVES LABEL CHANGE FOR FLOMAX FOLLOWING REPORT OF CATARACT SURGERY
COMPLICATIONS

Study Shows Prostate Drug Causes “Intraocular Floppy Iris Syndrome” Doctors
Must Anticipate Using Alternative Surgical Strategies


SAN FRANCISCO, Monday, November 14, 2005 – Who knew that the most commonly
prescribed prostate drug may complicate cataract surgery in male patients? David
F. Chang, MD and John R. Campbell, MD suspected this after conducting a recently
published study that examined the incidence of Intraoperative Floppy Iris
Syndrome (IFIS) in their cataract surgery practices.


“Flomax does not affect vision or eye health,” said Dr. Chang. “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. .


Dr. Chang and Dr. Campbell 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,” Dr. Chang said in his paper.


Dr. Chang 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,” concluded Dr. Chang.
“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.


The American Academy of Ophthalmology is the world’s largest association of
eye physicians and surgeons – Eye M.D.s – with more than 27,000 members. For
more information about eye health care or to find an Eye M.D. in your area,
visit the Academy’s Web site at www.aao.org.


Note to editors: For additional information on the intraocular floppy iris
syndrome, please visit Dr. Chang’s Web site at www.changcataract.com and go
to the link for “articles for physicians.”

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