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Alcon recalls its generic diclofenac
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FORT WORTH, Texas — Alcon Laboratories Inc. and its affiliate Falcon Pharmaceuticals Ltd. recalled its diclofenac sodium ophthalmic solution 0.1%, a topical ophthalmic non steroidal anti-inflammatory drug (NSAID), in the wake of reports of corneal perforations in patients using it.
“We are taking this action because of additional concern with reports of adverse events following aggressive use of topical ophthalmic NSAIDs,” said Stella Robertson, PhD, vice president of pharmaceutical products research and development.
“In earlier written communication to eye care professionals, Alcon emphasized the importance of using topical NSAIDs according to labeled instructions,” the company stated in a press release.
“Our data show that when used as labeled, Falcon diclofenac is safe and effective,” Dr. Robertson added. “However, we have become aware that off-label use is still prevalent.”
These adverse events appear to be more prevalent in patients with corneal problems, including those with dry eye or corneal epithelial defects. The company said that consulting physicians, including members of the American Society of Cataract and Refractive Surgery (ASCRS), recommended that Alcon remove diclofenac from the market.
CIBA Vision, which distributes the Voltaren brand of diclofenac, stated that “it remains confident in the safety profile of this product and will not recall or suspend distribution ... ” The company also stated it “firmly believes that the recent adverse event reports in the United States do not reflect on the safety profile of the entire topical NSAID class or the active ingredient diclofenac sodium.”
The ASCRS issued an alert based on individual physician reports and a preliminary survey it conducted among its members that topical ophthalmic NSAIDs may be causing corneal melts.