Fairfax, VA ­— Responding to the physician advisories circulated by ASCRS on intraoperative cataract procedure complications associated with the drug Flomax, representatives of the U. S. Food and Drug Administration (FDA) Friday, February 4, contacted ASCRS to request its help in urging ASCRS members to file reports on Intraoperative Floppy Iris Syndrome on the Administration’s MedWatch Web site (see web addresses below). 

“The FDA wants to look into IFIS, but it is stymied because it has not found any reports from physicians in their MedWatch drug-reporting files. Therefore, ASCRS, requests members to go to the MedWatch sites listed below.  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, 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.

Ms. Gisch explained that physicians would usually report an adverse drug affect to a drug manufacturer, which, by law, must transmitted to the FDA within 15 days.  The FDA would also like to receive reports directly from physicians to expedite their consideration of the issue, she said. 

The best way to submit cases to the FDA would be to use the online form at www.fda.gov/medwatch/report.htm .  Please note that the FDA would need an individual form filled out for each case.-- although if physicians are submitting multiple reports they can also download a fillable pdf version of the 3500 form atwww.fda.gov/medwatch/SAFETY/FDA-3500_fillable.pdf  which allows them to fill out the form from a desktop computer, save copies of the pdf's, and print out the one page form to fax to FDA at 1-800-332-0178.

The MedWatch website that describes in detail all these options for submitting voluntary reports is at: http:// www.fda.gov/medwatch/report/hcp.htm .

Gisch added that she encourages physicians to file reports to Boehringer-Ingelheim as well. Please report any unexpected effects or product problems to the Drug Information Unit by calling 1-800-542-6257(option 4).