FDA panel wants stricter contact lens labeling

June 10, 2008 Posted by AP Business, Matthew Perrone


FDA panel wants stricter labeling, testing standards for contact lens solutions
Eye care experts on 10 June 2008 recommended sterner labeling and more thorough testing of contact lens solutions to prevent eye infections.
A Food and Drug Administration panel of experts endorsed a host of changes to lens products, including: warnings not to reuse cleaning solution, discard dates on lenses and a recommendation to replace contact lens cases frequently.
So-called multipurpose solutions have been on the market for a decade, all but replacing older systems that use several formulas to rinse and clean contacts.
But in the past two years two popular formulas from Bausch and Lomb and Advanced Medical Optics were separately linked to hundreds of serious eye infections.
The Centers for Disease Control and Prevention concluded in 2006 that Bausch & Lomb’s MoistureLoc solution played a key role in an outbreak of a potentially blinding fungal infection that affected 180 people. In 2007, CDC linked Advanced Medical Optics’ Complete Moistureplus solution to a similar-sized outbreak of a rare eye-infecting parasite.
FDA is reviewing the safety and effectiveness of products on the market and is expected to adopt its panel’s recommendations.
Companies that would be affected by the proposals include Alcon Inc., Ciba Vision and the Cooper Companies.
Under one recommendation, all cleaning solutions would carry "rinse and rub" instructions, indicating users should rub the surface of the contact to clean it. Many eye doctors already recommended rubbing to remove dirt and bacteria from the lens. But products from Bausch & Lomb and Alcon Inc. carry ‘no rub’ labeling, indicating rubbing is not necessary for cleaning.
Agency scientists stressed the importance of following product labeling, reporting 80 percent of problems with contact lenses are caused by users not following directions.
"This is a very unique medical device in that patients have enormous control over the rate of infection," said Malvina Eydelman, director of the agency’s ophthalmic device division.
But panelists also said companies could improve their products by testing them against more types of bacteria and fungi.
Advanced Medical Optics’ withdrew its solution last year after government scientists linked it to a rare eye-infecting parasite called Acanthamoeba keratitis. It is not among the bacteria and fungi FDA currently requires products be tested against.
Panelists overwhelmingly said FDA should require companies test their solutions against the parasite before gaining market approval.

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