November 01, 1999
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ASCRS clarifies NSAID alert

Alcon has halted its NSAID distribution.

VIENNA — Further investigation of an outbreak of corneal melts has prompted the American Society of Cataract and Refractive Surgery (ASCRS) to clarify previous alert messages about topical ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs).

Announcing the clarification here at the European Society of Cataract and Refractive Surgeons, Kenneth J. Rosenthal, MD, noted “the geographic and temporal relationships to reported cases [of severe corneal melt requiring surgical intervention] and the presence of DSOS in the marketplace.” DSOS (Diclofenac Sodium Ophthalmic Solution, distributed by Alcon Laboratories’ subsidiary Falcon) is available only in North America, and ASCRS has found no cases of severe corneal melt outside North America.

After the initial ASCRS advisory was released, Alcon recalled DSOS.

“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.