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It has been exactly one year since John R.
Campbell, M.D., and I first described a new
small pupil syndrome—intra-op floppy iris
syndrome (IFIS) due to Flomax
(Boehringer-Ingelheim Pharmaceuticals, Inc.,
Ridgefield, Ct.)—in an article in EyeWorld.1
What followed was an important test of the speed
of modern medical communication.
As Dr.
Campbell and I reviewed the data from our two
complimentary clinical studies, we realized that
ophthalmologists should be alerted to this
association as quickly as possible. We also
recognized that, because Flomax is the leading
drug for benign prostatic hyperplasia, we would
need strong scientific evidence to support our
claims. Our preliminary findings were first
announced in the January 2005 EyeWorld article.
That same month, the ASCRS circulated an
e-mail/fax alert about IFIS to its membership
that provided a link to our article online
before most members had even received the print
issue. The ASCRS formed a Flomax advisory task
force that helped to draft letters to the Food
and Drug Administration (FDA), the American
Urological Association, and the manufacturer of
Flomax. All of the ophthalmic trade journals
promptly featured e-mail news briefs and print
articles on IFIS.
I first mentioned IFIS
during my complications course at the 2004 AAO
annual meeting. Almost immediately, course
attendees relayed this information across the
ASCRS EyeMail list serve. Within days of the
ASCRS alert, ophthalmologists from around the
world posted numerous experiences with IFIS on
this forum. These e-mails quickly confirmed the
Flomax-IFIS association and its frequency. From
these postings, we also learned that IFIS could
occur in women taking Flomax for urinary
retention as well as in patients taking
nonspecific alpha-1 blockers such as Hytrin
(Abbott Laboratories, Abbott Park, Ill.),
Cardura (Pfizer Inc., New York), and Uroxatral
(Sanofi-Aventis, Bridgewater, N.J.). Perhaps
most important were the many postings sharing
surgical experiences and emerging techniques for
managing IFIS. Experiences with Healon5
(Advanced Medical Optics Inc., Santa Ana,
Calif.), atropine, intracameral phenylephrine
and epinephrine, iris hooks, pupil rings, and
bimanual microphaco were all discussed in real
time over the Internet.
The Journal of
Cataract & Refractive Surgery accepted and
expedited the publication of our paper in its
April 2005 issue.2 This publication coincided
with the presentation of our study and film
festival entry at the ASCRS’ annual meeting that
same month. The study’s peer-reviewed
publication gave much-needed scientific
credibility to our announcement, which until
that point had been questioned by the
manufacturer.
Through print and electronic
communications, the ASCRS and AAO recommended
and facilitated online reporting of IFIS cases
to both Boehringer and the FDA. With these
reports corroborating our published findings,
the FDA took the significant step of relabeling
Flomax with a warning about IFIS in October
2005. The agency also asked Boehringer to send a
“Dear Doctor” letter to all urologists,
ophthalmologists, and primary care physicians.
Reports to the FDA of IFIS with other alpha-1
blockers may result in their being relabeled
with the warning as well.
Because the
ability to recognize and anticipate IFIS reduces
the rate of surgical complications, the rapid
dissemination of emerging information about its
etiology and management was critical. Our system
of rapid online and print communications clearly
met the challenge. One can only imagine how much
more slowly this news might have traveled in the
pre-electronic age.
Chang DF,
Campbell JR. Surgeons report—a new small pupil
syndrome caused by Flomax. EyeWorld, Jan. 2005.
Chang DF,
Campbell JR. Introperative floppy iris syndrome
associated with tamulosin (Flomax). J Cataract
Refract Surg. 2005; 31:664-673
ABOUT THE
AUTHOR
 David F.
Chang,
M.D. is the chief medical editor of
Cataract & Refractive Surgery Today. This
editorial first appeared in the January 2006
edition of that publication. It is reprinted
here with permission. Contact Dr. Chang at
650-948-9123 or dceye@earthlink.net.
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