FDA News FOR IMMEDIATE RELEASE Eye Infections Associated With Soft Contact

[Guest guest]

FDA News

FOR IMMEDIATE RELEASE

P06-56

April 10, 2006

Media Inquiries:

Cruzan, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01354.html

Investigation of Serious Eye Infections Associated With Soft Contact

Lens Use and Contact Lens Solution

Consumers Are Advised to Follow Good Hygiene Practices and

Manufacturers' Instructions to Prevent Infection

The U.S. Food and Drug Administration (FDA) and the Centers for

Disease Control and Prevention (CDC) are alerting health care

professionals and their patients who wear soft contact lenses to an

increasing number of reports in the United States of rare but

serious fungal infections in the eye that can cause permanent loss

of sight. Some patients have reported a significant loss of vision,

resulting in the need for a corneal transplant.

A fungus called Fusarium has been identified as the cause of the

reported infections. As of April 9, 2006, 109 cases of suspected

Fusarium keratitis are under investigation by CDC and public health

authorities in 17 states of the U.S.

" This is a serious infection and soft contact lens users should be

mindful of the potential to develop this problem, " said Dr.

Schultz, director of the FDA's Center for Devices and Radiological

Health. " We're advising consumers to practice good basic hygiene and

follow manufacturers' instructions for proper use, cleaning and

storage of their lenses, and report any signs of infection to their

doctors. "

Clinicians who evaluate patients with microbial keratitis should

consider that a fungal infection may be involved and refer the

patient to an ophthalmologist, if appropriate to obtain a specimen

for laboratory analysis. In addition, the FDA and CDC are urgently

advising consumers to take precautions to prevent contamination of

the soft lenses and the products used to maintain them. These

preventive practices for contact lens wearers include the following:

Wash hands with soap and water, and dry (lint-free method) before

handling lenses.

Wear and replace lenses according to the schedule prescribed by the

doctor.

Follow the specific lens cleaning and storage guidelines from the

doctor and the solution manufacturer.

Keep the contact lens case clean and replace every 3-6 months.

Remove the lenses and consult your doctor immediately if you

experience symptoms such as redness, pain, tearing, increased light

sensitivity, blurry vision, discharge or swelling.

In addition, regardless of which cleaning/disinfecting solution

used, wearers may want to consider performing a " rub and rinse " lens

cleaning method, rather than a no rub method, in order to minimize

the number of germs and reduce the chances of infection.

Of the 30 patient cases fully investigated so far, 28 wore soft

contact lenses and two reported no contact lens use. Twenty-six of

the soft contact lens users who remembered which solution they used

during the month prior to the infection onset reported using a

Bausch & Lomb ReNu brand contact lens solution or a generic brand

manufactured by the same company. Five case-patients reported using

other solutions in addition to the ReNu brand, and 9 patients

reported wearing contact lenses overnight, a known risk factor for

microbial keratitis.

" It is important to note that some of the affected patients had used

other solutions in addition to the ReNu brand, and that the source

of this fungus has not yet been identified. But we're working with

CDC and Bausch & Lomb -- and we're investigating other possible

causes -- to prevent these infections, " Dr. Schultz added.

Bausch and Lomb has informed FDA that they are voluntarily stopping

shipment of the ReNu Moisture Loc product while they are continuing

to investigate the cause of these infections. Soft contact lens

users who have existing supplies of the Renu Moisture Loc should use

the product with caution and report any signs and symptoms of eye

infection to their doctors.

Clusters of Fusarium keratitis were reported among contact lens

users in Asia beginning in November 2005. In February 2006, Bausch &

Lomb voluntarily suspended sales of its ReNu multipurpose solutions

in Singapore and Hong Kong after multiple reports of the infection

among contact lens users there. No other jurisdictions have taken

similar action to date.

Fusarium species are normally found in many plants, soil, and tap

water. The annual risk of contact lens-related microbial keratitis

is estimated in most studies to be between four and 21 per 10,000

patients, depending on whether the lenses are worn only during the

day or continuously overnight.

Fungal keratitis can be associated with trauma to the surface of the

eye, immunodeficiencies, and contact lens use. Organisms associated

with contact lens-related keratitis are usually bacteria rather than

fungus, often arising from contamination of lens care products or

from contact lens storage cases.

Additional information is available on FDA's website:

Public Health Notice: www.fda.gov/cdrh/safety/041006-keratitis.html

Centers for Disease Control MMWR: www.cdc.gov/mmwr/

####

[Guest guest]

Doctors treating more contact lens users for fungal infections

Infection can scar the cornea and blind its victims, though that

outcome is rare.

/ Associated Press

http://detnews.com/apps/pbcs.dll/article?

AID=/20060406/LIFESTYLE03/604060327/1040/LIFESTYLE

ORLANDO, Fla. -- Alison Bregman- felt as if lightning had

struck her right eye, or someone had pulled skin out of it. For

almost a month she could not work, drive or watch television.

" I'd never felt so much pain, " the 30-year-old social worker said.

It was not until several doctor visits later that Bregman-

was diagnosed with a fungal eye infection, a difficult-to-treat

condition that can cause blindness.

Some U.S. doctors are seeing a disturbing number of such infections

in contact lens wearers like Bregman-.

She and 20 others have been treated this year at the University of

Miami's Bascom Palmer Eye Institute, which typically sees that many

sufferers in an entire year. Twelve of those cases involved patients

with contact lenses, while previously fewer than 2 percent of those

infected wore them.

The federal Centers for Disease Control and Prevention is watching

the situation and said it has received reports of about 50 possible

cases in 12 states this year. But because tracking of the disease is

spotty, the CDC cannot say for certain whether cases are on the rise.

Singapore health officials noticed a spike in January. Cases have

also been reported in Malaysia and Hong Kong.

The fungus, called fusarium, is commonly found in plant material and

soil in tropical and subtropical areas. Without eyedrop treatment,

which can last two to three months, the infection can scar the

cornea and blind its victims, though that outcome is rare.

" The question is why all of the sudden contact lens users were

targeted by this organism, whereas before they have not been, " said

Dr. Alfonso, medical director of the Bascom Palmer Eye

Institute. " The fungus has been around, contact lenses have been

around -- why have they formed a marriage now? "

Alfonso said the only common denominators are that most patients

wore contacts and lived in a warm place where the fungus grew

abundantly.

Dr. Park, a CDC epidemiologist, would not identify the

states that have reported cases, but said one was a cold-weather

state.

" It's more common in Southern states, but it's still a rare

infection. We're talking one in 10,000 or something, " Park

said. " The fact that we've seen cases from cooler climates makes us

a little suspicious. "

--- In , " tigerpaw2c " <tigerpaw2c@...>

wrote:

>

> FDA News

> FOR IMMEDIATE RELEASE

> P06-56

> April 10, 2006

> Media Inquiries:

> Cruzan, 301-827-6242

> Consumer Inquiries:

> 888-INFO-FDA

>

> http://www.fda.gov/bbs/topics/NEWS/2006/NEW01354.html

>

> Investigation of Serious Eye Infections Associated With Soft

Contact

> Lens Use and Contact Lens Solution

>