Fairfax, VA – On January 21, the American Society of Cataract and Refractive Surgery (ASCRS) Executive Committee formed the ASCRS Flomax Working Group to further investigate problems associated with the drug Flomax (Boehringer-Ingelheim Pharmaceuticals, Inc., of Ridgefield, CT) and provide information that can be used to develop appropriate recommendations for clinicians and the US Food and Drug Administration (FDA).
The Working Group is chaired by ASCRS EyeMail Editor J. E. “Jay” McDonald, MD, and includes David F. Chang, MD, a member of the ASCRS Cataract Clinical Committee, and Samuel Masket, MD, a member of the ASCRS Executive Committee. The action follows the January 13 issuance of an ASCRS physician advisory concerning Intraoperative Floppy Iris Syndrome (IFIS) – a new small pupil syndrome described by Drs. Chang and John Campbell – that appears to be associated with the use of Flomax.
Flomax, according to many in the urological community, is one of the most effective and widely prescribed drugs for the treatment of benign prostatic hypertrophy (BPH) a common condition that affects men in the same age group as those likely to develop cataracts. The drug is also prescribed off-label to women with urinary retention, whose symptoms are ameliorated by the drug, which relaxes muscles in the bladder neck.
Dr. Chang is organizing a multi-center investigation of cataract surgery outcomes in patients taking Flomax. “Urologists and their patients will want to know whether Flomax can still be safely prescribed for those that may need cataract surgery,” said Dr. Chang. “In our original study, the surgeons did not have prior knowledge of when IFIS would occur.” This prospective study, involving approximately 10 practices, will evaluate whether there is an increased complication rate with cataract surgery in patients on Flomax. The surgeons will manage the pupil using one of three methods at their own discretion – iris retractors, pupil expansion ring, or Healon 5 (with low flow/low vacuum parameters). “These are methods that most practicing surgeons would be able to use. We hope to be able to report the complication rate and operative results in 100 consecutive pooled Flomax cases fairly quickly,” said Dr. Chang.
On January 31, ASCRS President Priscilla Arnold, MD, spoke with the President of the American Urological Association (AUA), Brendan Fox, MD, to brief him on the concerns relating to the use of Flomax.
“I emphasized that we were not suggesting a change in prescribing patterns at this time,” said Dr. Arnold. “He was very open to what we had learned and expressed his interest in communicating it to the urological community — especially what we learn from the follow-up investigation,” she added.
Dr. Fox said that the information in the January 13, ASCRS Flomax Advisory (Click Here) would be communicated to the AUA members.
“We will look to Dr. Chang’s multicenter study to provide us with sound data from which we will then consider an appropriate course of action with regard to potential recommendations — if appropriate — to ophthalmologists, other physician groups, and the FDA,” said Dr. Arnold.
On February 2, the FDA’s Division of Reproductive and Urological Drug Products, responding to the ASCRS physician advisory, contacted ASCRS for additional information on the IFIS syndrome and problems ophthalmologists have encountered with it.
The January issue of EyeWorld featured the first written report of two studies performed by Dr. Chang and John R. Campbell, MD. These separate prospective and retrospective studies — which totaled more than 1,600 combined patients — sought to characterize the features, incidence, cause, and management of IFIS. The results of the studies have been submitted for publication in the Journal of Cataract & Refractive Surgery, and will also be reported at the ASCRS·ASOA Symposium & Congress, April 15-20, Washington, D.C.
ASCRS’ EyeMail service continues to provide a forum for ophthalmologists to discuss their experiences with Flomax patients and seek assistance in dealing with them, said Dr. McDonald.
