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Alcon halts distribution of two NSAIDs
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FORT WORTH, Texas — Alcon Laboratories stopped distributing its two ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs), Diclofenac Sodium Ophthalmic Solution and Profenal (suprofen) Sterile Ophthalmic Solution 1%, following anecdotal reports of severe adverse corneal effects in patients receiving NSAIDs postoperatively.
ASCRS alert started it all
On August 3, the American Society of Cataract and Refractive Surgery (ASCRS) cautioned its members to avoid using NSAIDs after anterior segment surgery, based on a survey conducted among its American members.
ASCRS sent out 5,500 surveys and received 1,100 responses. Among respondents, 105 wrote that they saw corneal melts. ASCRS is now trying to determine which brands were prescribed and which brands were actually dispensed to those patient affected, as well as whether there is any epidemiological or statistical significance to those preliminary reports.
Alcon announced August 20 that it would halt distribution of its two NSAIDs and investigate the reports of adverse effects more thoroughly.
“We are greatly concerned about the occurrence of serious corneal adverse events reported in the United States associated with the aggressive use of topical NSAIDs before, during and after cataract surgery,” said Stella Robertson, PhD, vice president of research and development for Alcon’s pharmaceutical products, in a company press release.
Alcon’s investigation has included visits to physician’s offices, telephone interviews with physicians and talks with ASCRS and the Food and Drug Administration.
Aggressive use cited
The company said its talks with physicians revealed that a preponderance of the reported adverse events occur in cataract surgery where doctors aggressively use peri- and intraoperative NSAIDs. Alcon said its investigations suggest that the increase in reported events correlates with both a general increase in topical NSAID use and an increased use of diclofenac in association with ocular surgery.
Following approval of its generic diclofenac on May 4, 1998, and its market introduction in August 1998, Alcon distributed more than 410,000 units through its affiliate Falcon.
Adverse events appear to be more prevalent in patients with corneal problems, including those with dry eye or corneal epithelial defects, the company said in its August 20 release. The potential for topical NSAIDs to slow or delay healing and cause keratitis and corneal erosions has been previously recognized.
Extent of problem unknown
However, the patterns of pre-, peri- and extended postsurgical NSAID use on the occurrence and severity of corneal adverse events are not well understood, according to Alcon. Also, the association of adverse events with particular subsets of patients and the extensive concomitant use with other medications, particularly topical steroids, are not fully known.
“We are confident that our products, when used according to label directions, are safe and effective,” Dr. Robertson said. “However, we have taken this step be-cause of the importance of these issues to our customers and their patients. Patient safety is our number one concern.”
The company has also started discussions with the FDA to create stronger labeling that will specifically addresses the potential for problems associated with topical NSAID use. Such changes could include improved directions for use, as well as more warnings and precautions concerning the potential for serious corneal adverse events.
For Your Information:
- Mary Dulle, director of corporate communications for Alcon Laboratories Inc., can be reached at 6201 South Freeway, Fort Worth, TX 76134; (817) 551-8058; fax (817) 568-7126; e-mail: mary.dulle@alconlabs.com.