Tuesday, September 12, 2006

Contact Lens Solution Pulled From Market

(HealthDay News) -- U.S. vision care company Bausch & Lomb is permanently removing from the market a popular contact lens product associated with several serious fungal infections that can cause blindness.
"It appears that the ReNu with MoistureLoc does have a higher risk [of Fusarium keratitis]," said Dr. Daniel Schultz, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, at a Monday teleconference. "We certainly support the company's decision to remove this product from the market worldwide."
As of Friday, the U.S. Centers for Disease Control and Prevention (CDC) had received reports of 122 confirmed cases of Fusarium keratitis. According to the FDA, a majority of the confirmed cases have been associated with ReNu with MoistureLoc Multipurpose Solution -- a number that is disproportionately high given the product's market share.
Some 30 million Americans wear contact lenses, and about 2.3 million use MoistureLoc, according to the Associated Press.
While ReNu MultiPlus, ReNu Multi-Purpose and generic brands were also initially suspected, the FDA now believes that these products do not pose a problem.
"There is a baseline rate that is associated with a number of other products, but clearly, there is a much, much higher rate associated with MoistureLoc that is way above what would be expected based on market share and the percentage of use," Schultz said. "We need to continue to collect information, but, at this point, our scientific conclusion is pretty clear that the association is, in fact, just with the MoistureLoc solution."
The Fusarium fungus is usually found in tropical or subtropical soils. If left untreated, infection with the fungus can cause blinding scars to the cornea. According to the AP, at least 8 infected patients have so far required corneal transplants.
In a statement to consumers released Monday, Bausch & Lomb chief executive Ronald Zarella said the company decided to permanently withdraw ReNu MoistureLoc "because our Number One priority is the safety of our customers. We want you to have complete confidence in our products."
The eye-care product maker first stopped sales of ReNu with MoistureLoc on April 13, 2006, following reports of an unusually high number of fungal infections in users of the product.
Following that action, the company conducted an internal investigation and, on May 11, company representatives met with FDA officials for about two hours to share the findings.
FDA officials were not clear on the exact reason for the spike in infections.
"It's a complex interaction," Schultz said. "There are a number of ways in which these products are used, and the way that they're stored, and the way that the production is used in conjunction with the case and the contact lens. If a number of those factors come into play in conjunction with the particular formulation of this particular solution, that can lead to a higher than normal incidence of Fusarium infection. There does appear to be an association between the formulation itself, as well as certain use patterns, in creating this higher-than-normal incidence of these particular infections."
Schultz deferred more detailed explanations to the company.
The CDC and the FDA have been inspecting the Bausch & Lomb plant and facilities in Greenville, S.C., since March 22. That inspection is being finalized, and officials would not comment specifically on any findings.
The FDA's Schultz said agency experts "expect to have certain observations that will become public within the next few days. All I would like to say at this particular time is that we certainly expect that there will be some issues related to good manufacturing practices."
At the same time, he added, "there does not appear to be a direct relationship between those findings and this fusarium outbreak."
And, in a prepared statement, Zarella said inspectors have so far failed to turn up any sign of "contamination, tampering or counterfeiting" at the plant.
Marketwatch reported Monday that the FDA had found some violations at the Greenville plant but the agency said the violations were unrelated to the fungal infection.
Clusters of the same fungal infection were reported among contact lens users in Asia beginning in November 2005. In February 2006, Bausch & Lomb voluntarily suspended sales of the ReNu multipurpose solutions in Singapore and in Hong Kong.

More information
For more on the recall, visit the U.S. Food and Drug Administration.

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