FDA Report - Fusarium Keratitis Contact Lenses

ReNu

Fusarium Keratitis - Multiple States, 2006

April 10, 2006

On March 8, 2006, CDC received a report from an ophthalmologist in New Jersey regarding three patients with contact lens--associated Fusarium keratitis during the preceding 3 months. Initial contact with several corneal disease specialty centers in the United States revealed that other centers also have seen recent increases in Fusarium keratitis. This report summarizes the public health response to date in the United States and provides important prevention messages for contact lens users.

Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and rarely, contact lens use (1--3). An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4--21 per 10,000 soft contact lens users, depending on whether users wear lenses overnight (4). Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, up to 35% of microbial keratitis cases are fungal keratitis, compared with 1% in New York (5,6). The proportion of fungal keratitis attributable to Fusarium spp. also varies by region, from 25% to 62% (1,2,5). First-line treatment includes topical and oral antifungal medications; patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation (3). Fusarium keratitis is not transmitted from person to person.

As of April 9, 2006, a total of 109 patients with suspected Fusarium keratitis were under investigation in multiple states. Case finding was conducted through postings on the Epidemic Information Exchange (Epi-X) and ophthalmology listservs and through queries of clinical microbiology laboratories. CDC is coordinating an investigation with public health authorities in California, Connecticut, Florida, Georgia, Iowa, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, and Vermont. The majority of patients have yet to be interviewed; however, of 30 patients for whom complete data were available, the median age was 48 years (range: 13--83 years), and 21 (70%) were female; infection onset occurred during June 15, 2005--March 18, 2006.

Twenty-eight patients (93%) wore soft contact lenses, and two (7%) reported no contact lens use. Among contact lens users, 26 (93%) remembered which solution they used during the month before infection onset or had retained the actual bottle. Of these, 26 (100%) reported using a Bausch & Lomb (Rochester, New York) ReNu brand contact lens solution or a generic-brand solution manufactured by Bausch & Lomb. Patients reported using various ReNu product types from multiple product lots. Five (18%) patients reported using other solutions in addition to the ReNu solution, including solutions made by Advanced Medical Optics, Inc. (Santa Ana, California) and Alcon (Fort Worth, Texas). Nine (32%) patients reported wearing contact lenses overnight, a known risk factor for microbial keratitis. Eight (29%) required corneal transplantation. Laboratory testing to evaluate product contamination, including typing of Fusarium spp. isolates, is ongoing.

Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in February 2006. At that time, Bausch & Lomb voluntarily suspended sales of its ReNu multi-purpose solutions in Singapore and Hong Kong, pending investigation, after multiple reports of Fusarium keratitis among contact lens users there (7).

An ongoing investigation by CDC, state and local health departments, and the Food and Drug Administration is under way to determine whether this cluster represents an increase of Fusarium keratitis infections and to determine the association, if any, of these cases with any product. Epidemiologic and laboratory studies will help define specific activities, hygiene practices, or products that place persons at increased risk for Fusarium keratitis.

Measures to reduce the risk for microbial keratitis can be instituted immediately by contact lens users and include the safe handling, storage, and cleaning of contact lenses. Specifically, contact lens users should wash their hands with soap and water and dry them before handling lenses, wear lenses according to the schedule prescribed by eye-care practitioners and solution manufacturers, and follow guidelines for cleaning and storing lenses provided by eye-care practitioners and solution manufacturers. Contact lens users with questions about which solutions are best for them should consult their eye-care professionals and carefully weigh risks and benefits.

Clinicians evaluating contact lens users with signs or symptoms of keratitis, such as unusual redness, eye pain, tearing, discharge, or sensitivity to light, should consider fungal keratitis and refer the patient to an ophthalmologist, if appropriate. Clinicians should consider obtaining clinical specimens (e.g., corneal scrapings) for culture before initiating treatment. Clinicians or microbiology laboratories should report cases of Fusarium keratitis to state and local health departments or directly to CDC at telephone, 800-893-0485. Fusarium isolates should be submitted to state laboratories according to instructions provided by local and state public health laboratories.

Reported by:

MA Barry, MD, J Pendarvis, MPH, Boston Public Health Commission. J Rosenberg, MD, S Chen, MPH, California Dept of Health Svcs. P Mshar MPH, Connecticut Dept of Public Health. F Leguen, MD, Miami-Dade County Health Dept. C Robertson, MD, C Genese, MBA, C Tan, MD, E Bresnitz, MD, New Jersey Dept of Health and Senior Svcs. G Johnson, M Anand, MPH, P Smith, MD, New York State Dept of Health. MA Kainer, MPH, Tennessee Dept of Health. J Saviola, OD, M Eydelman, MD, D Schultz, MD, Food and Drug Admin. K O'Donnell, PhD, US Dept of Agriculture. BJ Park, MD, A Srinivasan, MD, K Wannemuehler, MS, M Arduino, PhD, J Noble-Wang, PhD, L Jacobson, M Brandt, PhD, S Fridkin, MD, National Center for Infectious Diseases; D Chang, MD, LA Burwell, MD, LR Carpenter, DVM, FMT Lewis, MD, JK Schaffzin, MD, PhD, L Sosa, MD, EIS officers, CDC.

References

1. Rosa RH Jr, Miller D, Alfonso EC. The changing spectrum of fungal keratitis in south Florida. Ophthalmology 1994;101:1005--13.
2. Tanure MA, Cohen EJ, Sudesh S, Rapuano CJ, Laibson PR. Spectrum of fungal keratitis at Wills Eye Hospital, Philadelphia, Pennsylvania. Cornea 2000;19:307--12.
3. Thomas PA. Fungal infections of the cornea. Eye 2003;17:852--62.
4. Poggio EC, Glynn RJ, Schein OD, et al. The incidence of ulcerative keratitis among users of daily-wear and extended-wear soft contact lenses. N Engl J Med 1989;321:779--83.
5. Liesegang TJ, Forster PK. Spectrum of microbial keratitis in south Florida. Am J Ophthalmol 1980;90:38--47.
6. Asbell P, Stenson S. Ulcerative keratitis. Survey of 30 years' laboratory experience. Arch Ophthalmol 1982;100:77--80.
7. Singapore Ministry of Health. Increasing incidence of contact lens related fungal corneal infections (update 3). February 21, 2006. Available at http://www.moh.gov.sg/corp/about/newsroom/pressreleases/details.do?id=36077601.

U.S. Food and Drug Administration (FDA)

Legal Help for ReNu Consumers with Fusarium Keratitis

If you or a loved one have used, or currently use, ReNu, ReNu with MoistureLoc or ReNu MultiPlus and have been recently diagnosed with keratitis, then you may have a right to file individual legal action against Bausch & Lomb. Due to the nature of this serious infection, ReNu consumers diagnosed with keratitis are urged to contact an attorney immediately after they have been informed of their diagnosis. Many important legal issues need to be addressed after a keratitis diagnosis that can possibly affect the outcome of civil litigation. The laws and theories of liability in each state are varied and can limit the amount of time a consumer has to file a lawsuit (statute of limitations).

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