Fairfax,
VA—The FDA is asking cataract surgeons to report any
incidents of intraoperative floppy iris syndrome (IFIS)
that they have experienced on the agency's MedWatch Web
site.
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The request is in response to
physician advisories circulated by the American Society
of Cataract and Refractive Surgery (ASCRS) on
intraoperative cataract procedure complications
associated with the drug tamsulosin hydrochloride
(Flomax, Boehringer-Ingelheim Pharmaceuticals,
Ridgefield, CT). IFIS is a new small pupil syndrome
described by David F. Chang, MD, and John Campbell that
may be associated with the use of tamsulosin.
"The FDA wants to
look into IFIS, but it is stymied because it has not
found any reports from physicians in its MedWatch
drug-reporting files. Therefore, ASCRS requests members
to go to the MedWatch sites (see box). Please note that
you can file multiple patient experiences on a single
form and it is not necessary to fill in all of the
information requested," said J.E. "Jay" McDonald, MD,
ASCRS Eyemail Editor.
"We need these to
gather information before we can determine what action,
if any, is appropriate," said Paula Gisch, safety
evaluator, FDA Division of Reproductive and Urological
Drug Products.
Gisch explained that
physicians would usually report an adverse drug effect
to a drug manufacturer, which by law must transmit it to
the FDA within 15 days. The FDA would also like to
receive reports directly from physicians to expedite
consideration of the issue, she explained.
In January, ASCRS'
executive committee formed a Flomax Working Group to
investigate problems associated with the drug, and
provide information to develop appropriate
recommendations for clinicians and the FDA.
The group is chaired
by Dr. McDonald and includes Dr. Chang and Samuel
Masket, MD. The action follows the Jan. 13 issuance of
an ASCRS physician advisory concerning IFIS. Tamsulosin
is widely prescribed for the treatment of benign
prostatic hyperplasia (BPH), a common condition that
affects men in the same age group as those likely to
develop cataracts. Tamsulosin is also prescribed
off-label to women with urinary retention to relax
muscles in the bladder neck.
Dr. Chang is
organizing a multicenter investigation of cataract
surgery outcomes in patients taking tamsulosin. This
prospective study will involve about 10 practices.
Surgeons will manage the pupil using one of three
methods at their discretion: iris retractors, pupil
expansion ring, or Healon 5.
