Anticipate silodosin-IFIS link, surgeon says

November 5, 2008

History-taking is a little more time-consuming for cataract surgeons with the recent FDA approval of silodosin capsules (Rapaflo, Watson) for the treatment of symptoms due to benign prostatic hyperplasia.

Rockville, MD-History-taking is a little more time-consuming for cataract surgeons with the recent FDA approval of silodosin capsules (Rapaflo, Watson) for the treatment of symptoms due to benign prostatic hyperplasia.

“This product will provide another treatment option for men suffering symptoms of an enlarged prostate,” said George Benson, deputy director of the FDA Division of Reproductive and Urological Products.

Silodosin, however, is pharmacologically similar to tamsulosin (Flomax, Boehringer Ingelheim Pharmaceuticals), which is associated with intraoperative floppy iris syndrome (IFIS), a complication that can occur during cataract surgery. Ophthalmologist David F. Chang, MD, told the American Academy of Ophthalmology that cataract surgeons, therefore, should expect that this drug also will be associated with IFIS. Dr. Chang and John R. Campbell, MD, first described IFIS in 2005.

An FDA press release about the drug approval instructs patients planning cataract surgery to notify their ophthalmologists if they are taking silodosin, and Dr. Chang also recommended that cataract surgeons ask their patients whether they are taking or have taken the drug.

Consumers and health-care professionals may report adverse events to the FDA’s MedWatch program at 800/FDA-1088; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or online at www.fda.gov/medwatch/report.htm.