JAMA Urges Black Box Warning for Flomax

Toronto, ONThe TV images depict middle-aged men and seniors enjoying their golf games and other outdoor pursuits without the pain or discomfort of urinary problems—often the bane of older men with enlarged prostates. However with Flomax (tamsulosin hydrochloride) there is more than meets the eye…literally. And a respected medical journal is calling for a Black Box warning for Flomax.

A new study published in the current issue of the Journal of the American Medical Association (JAMA) suggests that Flomax has been shown to cause floppy iris syndrome, a condition that can complicate cataract surgery.

An accompanying editorial in JAMA calls for a black box warning for the popular medication.

The problem has to do with the way Flomax works. Tamsulosin hydrochloride is believed to relax the smooth muscle in the prostate and bladders of older men with enlarged prostates, thus easing urinary problems.

However, the drug also appears to have a similar affect on smooth muscle in the iris of the eye, negatively impacting cataract surgery. The fact that Flomax and cataract surgery are both geared to a similar demographic can make for a huge headache, for both the patient and the medical community.

The research for the current study was based in Toronto and is the first large analysis of serious adverse events in patients taking Flomax following cataract surgery. The post-surgical complications experienced by 96,128 male cataract surgery patients aged 66 and older were studied between 2002 and 2007. All the patients were from Ontario.

In Toronto Dr. Chaim M. Bell and his colleagues at St. Michael's Hospital in Toronto determined that about 7.5 percent of patients who were prescribed Flomax over the 14 days prior to surgery suffered a serious post-surgical complication, compared against 2.7 percent of patients who had not used tamsulosin hydrochloride.

Those complications included retinal detachment, inflammation around the eye or even a lost lens.

The manufacturer, Boehringer Ingelheim Pharmaceuticals Inc., notes that information accompanying Flomax already cautions patients who are considering cataract surgery to advise their ophthalmologists as to their current, or prior history with the drug. Surgeons, according to the manufacturer, "should be prepared for possible modifications to the surgical technique."

It is not known at this juncture what position the US Food and Drug Administration (FDA) has taken, if any, with regard to the Flomax study in Toronto. However the implications are steep, given that nearly three out of four men are impacted by an enlarged prostate by age 70, and according to the New York Times about two million cataract procedures are performed in the US each year.

Dr. Bell, in Toronto does not necessarily advise the abrupt stopping of Flomax prior to cataract surgery. "We can't say that that's a good thing to do."

That said, "…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.'"