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OSN SuperSite Breaking News 11/11/2005 FDA approves Flomax labeling change The labeling for a drug used to treat enlarged prostate will be altered to reflect information recently described regarding intraoperative floppy iris syndrome, a condition that occurs during cataract surgery in men who have taken the drug. The approval of the labeling change for Flomax (tamsulosin HCl, Boehringer Ingelheim) was announced in a letter from the Food and Drug Administration to the manufacturer. Flomax is an antagonist of alpha-1a adrenoceptors in the prostate, according to prescribing information for the drug. It is by the FDA approved for the treatment of benign prostatic hyperplasia, a condition affecting only men. As reported first on the OSN SuperSite, David F. Chang, MD, and John R. Campbell, MD, found that current or previous use of Flomax may induce intraoperative floppy iris syndrome (IFIS) in patients undergoing cataract surgery. In a review of cataract patients, the researchers found a 2.3% incidence of IFIS, and 95% of those with the syndrome had a history of Flomax use, Dr. Chang said at that time. If a patient stops using tamsulosin 1 or 2 weeks before surgery, the risk of IFIS is reduced but not prevented, he said. As a result of Drs. Chang and Campbell’s findings, Boehringer Ingelheim will include information about the syndrome in its Flomax labeling under general precautions. According to information submitted to the FDA, Boehringer Ingelheim will include the statement: “The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings or viscoelastic substances. The benefit of stopping alpha-1 blocker therapy prior to cataract surgery has not been established.” | |||
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