FAIRFAX, Va., Aug. 22 /PRNewswire/ -- The American Society of
Cataract and Refractive Surgery (ASCRS), the American Academy of
Ophthalmology (Academy) and the American Urological Association
(AUA) today advised patients taking certain drugs to treat prostate
enlargement to inform their eye surgeon about these medications
before undergoing eye surgery. These drugs can potentially cause
complications during cataract surgery. However, preliminary results
of a new study found that these patients can still have successful
surgery if their surgeon knows they are taking or have taken these
drugs and alters the surgical technique.
Tamsulosin (Flomax(R)) is the most commonly prescribed drug for
prostate enlargement, or benign prostatic hyperplasia (BPH). By
facilitating more complete emptying of the bladder, Flomax decreases
the need to urinate during the middle of the night. However, Flomax
and other similar systemic drugs called alpha-blockers can potentially
cause difficulty during cataract surgery, particularly if the eye
surgeon has not been forewarned. For this reason, ASCRS, the Academy
and AUA advise patients who are taking or have taken alpha-blocker
prostate drugs such as Flomax, to inform their ophthalmologist before
surgery. Other drugs in this alpha-blocker class include, terazosin
(Hytrin(R)), doxazosin (Cardura(R)), and alfuzosin (Uroxatral(R)).
The alpha-blocker drugs are all regarded as being safe and effective
for the treatment of urinary symptoms due to prostate enlargement
without harming the eyes.
The effect of Flomax on cataract surgery:
In 2005, David F. Chang, MD, and John R. Campbell, MD, completed
both a retrospective and a prospective study of 1,600 patients and
identified a new problem that occurs during cataract surgery in
patients using Flomax. They called the condition Intraoperative
Floppy Iris Syndrome (IFIS).
The iris, the part of the eye that gives it its color, opens
and closes in response to varying light levels. Because the iris
is located in front of the cataract, the pupil (opening in the iris)
must be widely dilated in order to perform the surgery. A large
pupil is obtained by using dilating drops that stimulate the iris
dilator muscle. Chang and Campbell found that Flomax appears to
block this iris muscle, leading to troublesome behavior of the iris
during eye surgery. The iris tends to be floppy and the pupil may
suddenly constrict during the middle of surgery. If the iris problems
are not anticipated or prevented, there is an increased risk of
having surgical complications. Interestingly, they still found IFIS
in some patients who had been off the medication for two years.
"Flomax does not affect vision or eye health," Dr. Chang said. "But
it impairs the dilator muscle in the iris, and during cataract surgery
the pupil needs to stay dilated."
Following the publication of Chang and Campbell's findings, and
after receiving corroborative reports from other ophthalmologists,
the U.S. Food and Drug Administration (FDA) instituted a new label
warning for Flomax and other alpha-blocker drugs that reads: "The
patient's ophthalmologist should be prepared for possible modifications
to their surgical technique." In 2005, frequent discussion among
ophthalmic surgeons of problems posed by patients on Flomax resulted
in the formation of an ASCRS task force, chaired by Dr. Chang, which
developed recommendations for surgical techniques to be used during
cataract surgery on patients taking Flomax or other alpha-blockers.
The Academy will be including this information in its evidenced-based
Preferred Practice Pattern(R) guide (PPPs) for cataract care. These
PPP guides are followed by ophthalmologists worldwide.
Multi-center study of cataract surgery in Flomax patients
To assess the effectiveness of these techniques, a large multi-center
trial was undertaken at 10 centers around the country. More than
160 cataract surgeries were performed on patients taking Flomax
using these modified techniques. Dr. Chang reported the preliminary
results at the recent ASCRS Annual Symposium in San Francisco. The
study demonstrated that if the surgeon knew about the Flomax use
in advance, and if the modified surgical techniques were used, the
surgical success rate was excellent and the complication rate was
not increased in comparison to surgery on non-Flomax patients. Final
results of the study will be presented at the Academy's Annual Meeting
Several important conclusions can be drawn from this study, according
to Dr. Chang. "Although the drug can make cataract surgery more
difficult, if the surgeon knows in advance that the patient is or
has taken Flomax or another alpha-blocker drug, then appropriate
techniques can be used that provide excellent results," he said.
"Flomax is an excellent prostate medication, and there is no need
for patients to avoid it or stop taking it out of concern over eye
problems. However, the key is for patients to inform their ophthalmologist
when they are taking this or any other prostate drugs prior to eye
surgery. This is not something that you would ordinarily think to
tell your eye doctor."
Cataracts and prostate enlargement are both very common age-related
conditions. In men, enlargement of the prostate typically begins
around age 55. The condition prevents complete emptying of the bladder,
which in turn increases the frequency of urination. Urologists treat
prostate enlargement through the use of drugs and, if needed, surgery.
Alpha-blockers, such as Flomax, relax muscles in the enlarged prostate
in order to improve urinary outflow. This decreases the need to
urinate as frequently and allows men to sleep uninterrupted for
Cataracts are a progressive clouding of the lens of the eye and
are the most common age-related cause of worsening vision. Ophthalmologists
treat cataracts by surgically removing the cloudy natural lens and
replacing it with a clear artificial lens implant.