Personal Injury Law

?Black Box? Warning Label Suggested For Flomax Due to Complications From Cataract Surgery

Cataract surgery is the most commonly performed operation in the United States today, with nearly 2 million cataract operations performed in the United States each year. Benign prostatic hyperplasia (BPH), an enlarged prostate, is common in older men, affecting nearly 3 out of 4 men by the age of 70 years. BPH is often treated with tamsulosin hydrochloride (Flomax), an alpha-blocking drug that accounted for more than $1 billion in sales in 2007. This BPH/cataract combination is dangerous: A study to assess the risk of adverse events following cataract surgery in older men prescribed Flomax found that exposure to tamsulosin within 14 days of cataract surgery was significantly associated with serious postoperative ophthalmic adverse events.

The researchers discovered that those who took Flomax two weeks before the procedure were 2.3 times more likely to have a serious complication. 284 men (0.3%) had a complication in the 14 days following cataract surgery.

Among the complications:
? 175 men had a procedure for a lost lens or lens fragment;
? 35 men had a retinal detachment ;
? 26 men had both ;
? 100 men had suspected endophthalmitis, an inflammation within or around the eye.

A complication was deemed to have occurred if the patient had a physician service claim for any 1 of 4 procedures (vitrectomy, vitreous aspiration or injection, dislocated lens extraction, or air or fluid exchange) between 1 and 14 days after cataract surgery. Procedures occurring on the same day as the surgery were not included.

The new study, published in this week?s 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. Surgical complications were not seen among men who used other drugs in the same class of alpha blockers, the paper noted.

Flomax is manufactured by Boehringer Ingelheim Pharmaceuticals Inc. It 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 intraoperative floppy iris syndrome (IFIS). Billowing of the iris into the surgical field and poor pupillary constriction are potentially catastrophic barriers to successful cataract surgery.

This association has prompted warnings regarding the risk of IFIS for patients taking tamsulosin and undergoing cataract surgery. However, the warnings and noted precautions in reference materials focused only on the added intraoperative difficulty associated with tamsulosin and did not mention postoperative adverse events.

Such warnings are not nearly sufficient. The study?s authors state that because the combination of cataract surgery and tamsulosin exposure is relatively common, doctors should properly appraise their patients of the risks of drug therapy and preoperative systems should focus on the identification of tamsulosin use by patients.

Going further is an editorial by Alan H. Friedman, M.D. of the Mount Sinai School of Medicine, New York, that accompanied the article. Dr. Friedman suggested that federal authorities reassess Flomax’s safety data to determine if a black box warning is warranted. A black box warning is the most serious form of warning issued by the FDA about a drug, a warning reserved for what the FDA deems the most dangerous potential adverse events. The FDA will require the drug’s printed materials, both inside the packaging and on materials developed for the doctors who may prescribe the drug, to carry a warning about those adverse effects. That warning is surrounded by a printed black box.

This is what happened this past February when the FDA ruled that makers of the drug metoclopramide must put the black-box warning on the product’s package insert. Also sold as Reglan, Octamide and Maxolon, metoclopramide is used to treat certain gastrointestinal problems. If taken chronically, it can cause a serious neurological disorder called tardive dyskinesia (TD), a disorder, sometimes permanent, in which the tongue, mouth and jaw move uncontrollably in abnormal ways.

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Full post as published by Legal Blog on May 22, 2009 (boomark / email).