Reports Of Fungal Keratitis Infections In Contact Lens Wearers. The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have alerted healthcare professionals to increasing reports of Fusarium fungal eye infections in contact lens wearers.
The infections can cause permanent loss of sight, and a significant loss of vision in some patients has resulted in a need for corneal transplant, according to an alert sent yesterday from MedWatch, the FDA’s safety information and adverse event reporting program.
Thus far, the CDC has received 109 reports of suspected fungal keratitis from 17 different states. Although the majority of patients remain to be interviewed, data for 30 cases thus far have revealed that 28 occurred in wearers of soft contact lenses.
Of 26 patients who remembered which brand of lens products they used, all reported using a Bausch & Lomb ReNu solution or a generic brand manufactured by the same company. Five patients also reported wearing lenses overnight, a known risk factor for microbial keratitis; corneal transplants were required in 8 patients.
Because some patients had used additional contact lens solutions, the source of the fungus remains unclear. The FDA and CDC are continuing to investigate these case reports and identify specific behaviors that place contact lens wearers at increased risk for Fusarium keratitis.
Bausch And Lomb Stopped Shipment Of ReNu MoistureLoc
In the interim, Bausch & Lomb has voluntarily stopped shipment of the ReNu Moisture Loc product and recommends caution when using existing supplies. Sales of the ReNu multipurpose solutions have also been suspended in Singapore and Hong Kong due to multiple reports of infection among contact lens wearers there.
Clinicians are advised to consider the potential for fungal infection in patients presenting with microbial keratitis and to refer them to an ophthalmologist for specimen analysis if warranted.
The FDA and CDC are also urgently advising consumers to employ preventive measures in their use of soft contacts and associated maintenance products.
Hands should be washed with soap and water and dried using a lint-free method prior to handling lenses, which should be stored and cleaned according to physician and solution-manufacturer recommendations. The contact lens case should also be kept clean and replaced every 3 to 6 months.
Furthermore, regardless of the type of cleaning/disinfection solution used, wearers should consider using a “rub and rinse” rather than “no rub” method to minimize the risk for infection.
Contact lenses should be worn and replaced according to physician recommendations. Patients should be instructed to remove their lenses and contact their physician if they develop symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling.
Additional information regarding the risk for fungal keratitis in contact lens users may be obtained by contacting Nancy Pressly by fax to 1-301-594-2968, email to [email protected], or by correspondence addressed to the FDA Office of Surveillance and Biometrics (HFZ-510) at 1350 Piccard Drive, Rockville, Maryland, 20850. Calls to voice mail at 1-301-594-0654 will be returned as soon as possible.
Healthcare professionals are encouraged to report cases of fungal keratitis to the FDA’s MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
The FDA is requesting that the reports include information on contact lens solution trade names and lot numbers involved; lens type, trade name, and mode of wear (extended or daily wear); patient noncompliance with contact lens regimen (eg, overnight wear in daily wear lenses, not cleaning lenses); and results of all cultures taken (eg, corneal, conjunctival, contact lens, care solutions, lens case).
In addition, information regarding special patient characteristics should be supplied, including whether the patient was immunocompromised (eg, used topical or systemic corticosteroids or had diabetes) or had any ocular trauma, surgery, or chronic eye disorder. All topical ocular medications used to treat the patient should also be reported (including trade names and lot numbers if available).
Need Legal Help Regarding Contact Lens Fungal Keratitis Infections?
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