The medication, tamsulosin hydrochloride, sold under the brand name Flomax, is believed to relieve urinary problems in men with enlarged prostates by relaxing smooth muscle in the prostate and bladder. But the drug seems to have a similar effect on smooth muscle in the iris of the eye, complicating cataract surgery by causing a syndrome called floppy iris syndrome.
The study, published in a 2009 issue of The Journal of the American Medical Association, is the first large analysis of serious adverse events after cataract surgery in patients taking the drug. It was accompanied by an editorial suggesting that federal authorities consider a “black box” warning label for the drug.
Dr. Chaim M. Bell, an internist at St. Michael’s Hospital in Toronto, and his colleagues analyzed the post-surgical complications experienced by 96,128 men ages 66 and older who had cataract surgery in Ontario from 2002 to 2007.
Some 7.5 percent of patients who were prescribed tamsulosin hydrochloride in the 14 days before surgery suffered a serious complication after the operation, compared with 2.7 percent of surgery patients who had not used the drug, the analysis found. The complications included retinal detachment, a lost lens or inflammation around the eye.
“The take-home message to the physician is, ‘Before you put people on this medication, you might want to ask if they are having cataract surgery soon and might want to consider a different medication,’ ” Dr. Bell said.
But he did not advise abruptly stopping the use of the drug before cataract surgery. “We can’t say that that’s a good thing to do,” he said.
A statement released by Boehringer Ingelheim Pharmaceuticals Inc., maker of Flomax, said the drug patient information insert already tells patients considering cataract surgery that they should advise their eye surgeons if they are taking the drug or have done so, and that surgeons “should be prepared for possible modifications to the surgical technique.”
Although some women take the drug to treat kidney stones, female patients were not included in the analysis. Surgical complications were not seen among men who used other drugs in the same class of alpha blockers, the paper noted.
Nearly three of four men are affected by an enlarged prostate by age 70, and close to two million cataract surgeries are performed annually in the United States.
Originally puglished in the New York Times
By RONI CARYN RABIN
Published: May 19, 2009
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