FDA studies intraoperative cataract complication, prostate drug

March 15, 2005

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.

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.

"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.

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.