BPH: Black Box Warning for Tamsulosin?

RESEARCH HIGHLIGHTS BPH Black box warning for tamsulosin? ew data have prompted calls for the Serious adverse events in the safety information provided with immediate postoperative period Ntamsulosin tablets to be reassessed. were more than twice as likely to affect Blockade of α1a-adrenergic receptors men who had taken tamsulosin in the in the smooth muscle of the prostate and 2 weeks prior to surgery (adjusted odds bladder is a common first-line approach ratio 2.33). Exposure to other alpha- to management of symptomatic benign blockers during the same period did prostatic hyperplasia (BPH). Drugs that not increase the risk of complications facilitate this blockade also interfere with (adjusted odds ratio 0.91). That the α1a-receptor signaling in the iris. This can observed effect was specific to tamsulosin cause ‘intraoperative floppy iris syndrome’ may be a function of this drug’s superior (IFIS), a condition that is known to make selectivity for α1a-adrenergic receptors ophthalmic surgery more difficult. Solid relative to its counterparts, such as data have now confirmed that recent alfuzosin and doxazosin. Interestingly, exposure to the alpha-blocker tamsulosin the likelihood of adverse events was is associated with a markedly increased not elevated by less-recent use of risk of serious adverse events immediately alpha-blockers—including tamsulosin. after cataract removal. These findings raise several obvious The ramifications of the study, questions of clinical interest. Should men published in the May issue of the Journal discontinue tamsulosin therapy before of the American Medical Association, could ophthalmic surgery? Bell cautions that be far-reaching. Tamsulosin generated such a strategy could lead to acute urinary over US$1 billion in sales in 2007. BPH retention, and recommends weighing affects almost three-quarters of 70-year- this risk against the estimated number old men, and almost 2 million cataract needed to harm of 255. Should men operations are performed in the US switch to another alpha-blocker? As noted each year. by Alan Friedman in an Editorial that which ophthalmologists can encourage Chaim Bell from St Michael’s Hospital, accompanies the JAMA paper, IFIS can a co-operative approach to clinical Toronto, and his colleagues used a occur more than 12 months after cessation decision-making. nested case–control design to analyze of tamsulosin, indicating the potential Urologists should use this new data from several linked databases in futility of this approach. information when prescribing alpha- Ontario, Canada. Of more than 96,000 What, then, to do? According to blockers, making a point of questioning men aged at least 66 years who underwent Bell, emphasis needs to be given patients about any ophthalmic issues for cataract surgery, 284 experienced a to raising awareness and improving which they may seek future intervention serious ophthalmic adverse event in the communication among urologists, and opting for a non-tamsulosin regimen 2-week period immediately following ophthalmologists, pharmacists, patients, in men with cataracts. Direct-to-consumer the procedure. These complications and preoperative care teams. Bell advertising in the US already advises users included lens loss, retinal detachment, advocates preoperative identification of of tamsulosin to inform their doctor if and inflammation—all of which can patients taking tamsulosin, perhaps by they have this form of eye disease—Bell cause blindness. including tamsulosin on the high-risk agrees with Friedman’s suggestion that Most of the 284 cases were matched drugs checklist used to assess surgical strengthening the tone of prescribing to 4 controls each. The mean age of the candidates during preoperative clinics. information to ‘black box’ warning level case and control groups was 77 years. “[If they are aware of recent tamsulosin could also be helpful. Interrogation of the prescribing database exposure] surgeons can plan and prepare Suzanne J. Farley indicated that patients in both groups had for a potentially more complicated taken about 10 different medications in procedure or refer to someone with more the year prior to surgery. In the 14 days experience,” Bell told Insidermedicine Original article Bell, C. M. et al. Association between before their procedure, tamsulosin had (www.insidermedicine.com). Ensuring tamsulosin and serious ophthalmic adverse events in older been prescribed to 21 and 30 cases and a patient’s urologist receives a copy of men following cataract surgery. JAMA 301, 1991–1996 controls, respectively. their consult letter is another way in (2009). NATURE REVIEWS | UROLOGY VOLUME 6 | JULY 2009 | 345 © 2009 Macmillan Publishers Limited. All rights reserved.

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