It has been exactly 1 year since John R. Campbell, MD, and I first described a new small pupil syndromeintraoperative 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 complementary 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 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 Eye Mail 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, IL), Cardura (Pfizer, Inc., New York, NY), and Uroxatral (Sanofi-Aventis, Bridgewater, NJ). 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, CA), 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.