Advanced Search

FDA studies intraoperative cataract complication, prostate drug
Ophthalmology Times

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.

How to submit a case to the FDA
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.

Earn 1.5 CME Credits
The Role of VEGF in Neovascular AMD

Exudative age-related macular degeneration (AMD) is the leading cause of irreversible vision loss among the elderly in North America and Europe.

In Brief
Acuity improves with TTT, study says
Alcon files NDA for wet AMD drug
Alimera Sciences, CDS develop DME treatment
CPT code assigned for Keratoconus inserts
Crystalens patients keep 3-year accommodation
Clinical Resources
powered by Mediwire
View All Topics