Thursday, April 13, 2006

Bausch & Lomb Moistureloc -- fungus or coincidence?


April 11, 2006
Eye Infections May Be Tied to a Solution for Lenses

After 109 patients in 17 states became infected with severe fungal eye infections, federal health officials are investigating whether a popular contact lens cleaning solution might be the cause.

Bausch & Lomb stopped shipments but not sales of the solution, Renu with MoistureLoc, after initial reports found that many of those infected had used the product.

All 109 infection cases occurred between June 15, 2005, and March 18, and there may be many more. Eight victims required corneal transplants to avert blindness.

Officials have been able to investigate only 30 of the cases. Of those, 28 patients wore soft contact lenses, and all but two of those used Renu products for cleaning. Five of the 26 patients who used Renu products also used other cleaning products.

Dr. Daniel Schultz, director of the Food and Drug Administration's device center, said he did not know if or why Renu products might leave patients more susceptible to the infections.

"The data are not as clear or as specific as we would like," Dr. Schultz said. "We do believe there is a numerical association with the Bausch & Lomb Renu product. Within the analysis, we believe that the highest association is with the Renu with MoistureLoc solution."

A similar outbreak in February in Hong Kong and Singapore led Bausch & Lomb to stop shipping Renu with MoistureLoc to those countries, but health officials said that they had no suspicions then that such cases were also occurring in the United States.

Stores can continue to sell Renu until supplies run out, Dr. Schultz said. An estimated 30 million Americans wear soft contact lenses.

Federal inspectors are going over Bausch & Lomb's plant in Greenville, S.C., in an investigation that should be completed "within a matter of days," said Tim Ulatowski, an F.D.A. enforcement official.

In a prepared statement, Ronald L. Zarrella, Bausch & Lomb's chairman and chief executive, said that much remained unknown about the cases.

"Nonetheless, in the interest of public health, we will voluntarily suspend U.S. shipments of Renu with MoistureLoc while we pursue all appropriate steps to bring this investigation to a definitive conclusion," Mr. Zarrella said.

The concerns began on March 8 when a New Jersey ophthalmologist called the Centers for Disease Control and Prevention to say that he had seen three patients in the previous three months who were suffering from the rare fungal eye infection, Fusarium keratitis.

Centers officials called corneal disease specialists around the country and found that other doctors had also seen an increase in such cases.

Fungal infections are quite rare but are more likely to occur in the South. That so many cases occurred in New York and New Jersey caused particular concern, Dr. Schultz said.

Dr. Schultz said that the investigation into the infections was still early and that officials might arrive at other conclusions about what to do.

Dr. Schultz said that the drug agency was aware of the cases in Asia in February, but "we did not have evidence of cases here in the United States."

The centers called the drug agency on March 8 after it received the initial report from the New Jersey ophthalmologist and "we started having intensive discussions with the C.D.C. and the company," Dr. Schultz said.

Dr. Schultz called Bausch & Lomb's decision to stop shipments but not sales of its Renu with MoistureLoc product "a very appropriate and responsible action." He said the halt was done voluntarily. It is exceptionally rare for the drug agency to order a sales ban over the objections of a manufacturer.

Dr. Malvina B. Eydelman, an eye specialist with the F.D.A., said that patients using soft contact lenses who have redness, pain, tearing, discharge, an increased sensitivity to light or blurred vision should see an ophthalmologist. Doctors should be particularly alert to the possibility of fungal infections and take cultures before starting treatment.

The usual treatments for such infections are topical and oral antifungal medications. If these fail, surgery may be required, according to a bulletin released by the C.D.C.

Health officials also counseled contact lens users to wash their hands with soap and water and dry them before handling lenses. Dr. Eydelman said users should use a "rub and rinse" method of cleaning their lenses rather than a no-rub method.

Fungal infections happen most often after eyes have been hit directly with plant material. The infections are not contagious.

The drug agency has little ability to uncover drug or device dangers on its own. It relies on voluntary reports from doctors and patients, but such reports are rare and often difficult to interpret.

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