ReNu - FDA Public Health Advisory

[rbaker]

FDA PUBLIC HEALTH ADVISORY
Issued April 10, 2006

Dear Healthcare Practitioner

This is to inform you of a recent increase in the number of reports in the United States of a rare but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating this situation. At this time, Bausch and Lomb has agreed to stop shipping the ReNu MoistureLoc brand contact lens solution. This Notification will be updated as more information becomes available.

Current Testing

In an MMWR Dispatch dated April 10, 2006, CDC stated that it received reports of 109 cases of suspected fungal keratitis in 17 different states. Although the majority of case patients have yet to be interviewed, complete data are available for 30 of them. Twenty-eight of the 30 wore soft contact lenses. Preliminary information obtained by CDC from patient interviews indicates that 26 of these patients remembered which products they used, and that all 26 reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection. Patients reported using a variety of different ReNu types from multiple different product lots. Five of the patients reported using other solutions in addition to the ReNu product. Nine of the patients reported wearing lenses overnight, a known risk factor for microbial keratitis. Eight required corneal transplantation. Strain typing of the organism is ongoing.

CDC and FDA are investigating these case reports. Also, investigations by CDC, state and local health departments, FDA, and manufacturers of contact lens solutions are underway to define specific behaviors or products that place contact lens wearers at increased risk for Fusarium keratitis.

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 multipurpose solutions in Singapore and Hong Kong, pending their investigations, after multiple reports of Fusarium keratitis among contact lens users there.

Background on Microbial Keratitis

Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases,
immunodeficiency, and rarely, contact lens use. There are an estimated 30 million soft contact lens users in the United States; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users, depending on overnight lens use. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, fungal keratitis comprises up to 35% of microbial keratitis cases compared with 1% in New York. The proportion of fungal keratitis due to Fusarium spp. also varies by region, from 25-62% .

Recommendations

For healthcare providers:
* If a patient presents with a microbial keratitis, consider that a fungal infection may be involved and obtain a specimen for laboratory analysis.
* Refer patients to an ophthalmologist for immediate treatment.
* Report cases of fungal keratitis in contact lens wearers to FDA as noted below.

For contact lens wearers:
* 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.

FDA Advice to Patients on this topic can be found at http://www.fda.gov/cdrh/medicaldevicesafety/atp/041006-keratitis.html.

Reporting Adverse Events
FDA and CDC are very interested in gathering information related to fungal keratitis in contact lens users. We encourage you to report these infections to FDA. FDA will be sharing reported information with CDC. You can report directly to MedWatch, the FDA's voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.
Please include the following information (if available) on the MedWatch reporting form:
* Contact lens solutions trade names and lot numbers.
* Contact lens type, trade name and mode of wear (extended or daily wear).
* Patient non-compliance with contact lens regimen (e.g., overnight wear in daily wear lenses, not cleaning lenses).
* Results of all cultures taken (e.g., corneal, conjunctival, contact lens, care solutions, lens case).
* Special patient characteristics, including whether the patient was immunocompromised (e.g., used topical or systemic corticosteroids or had diabetes), or had any ocular trauma, surgery, or chronic eye problem.
* Topical ocular medications used to treat the patient (including trade names and lot number if available).

Getting More Information
If you have questions about this notification, please contact Nancy Pressly, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 301-594-0650 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://list.nih.gov/archives/dev-alert.html.

Sincerely yours,

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration

[Chris Ryser]

FDA News

FOR IMMEDIATE RELEASE
P06-56
April 10, 2006

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA




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. Daniel 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/

[Chris Ryser]

Officials Probe Eye Infection Outbreak


By ANDREW BRIDGES
The Associated Press
Monday, April 10, 2006; 6:37 PM

WASHINGTON -- Bausch & Lomb voluntarily suspended shipment of a contact lens solution after federal health officials linked it Monday to a fungal eye infection that can cause temporary blindness.

The Centers for Disease Control and Prevention is investigating 109 reports of Fusarium keratitis infection in patients in 17 states since June 2005.


See the whole article at: http://www.washingtonpost.com/wp-dyn...041001149.html

[shellrob]

We've had a few calls from patients today wondering if this is what's wrong with their eyes.

[bwitched24]

We had 5 calls yesterday about this as the local news ran a story on it the night before. Some of them were seriously freaking out.

[shellrob]

I had a couple more calls last night. It's crazy. Some think they ahve it and some just want to know what to look for. Man oh man.

[impact500]

B&L has issued a press release and will have ads in major newspapers Friday. They are asking US retailers to pull the product off their shelves.

[Chris Ryser]

Bausch & Lomb girds for solution-related losses
Healthcare products company also faces accounting issues; will not meet its 10-k filing deadline.
April 12, 2006: 5:20 PM EDT



CHICAGO (Reuters) - Bausch & Lomb set out Wednesday to assuage investor fears as retailers began pulling one of its contact lens solutions from shelves amid a U.S. government investigation over whether it is linked to a serious eye infection.

U.S. health authorities are looking into 109 cases of Fusarium Keratitis, a rare but serious eye infection that could cause permanent vision loss if left untreated.

Twenty six of those patients said they had used Bausch & Lomb products or generic versions made by the company. Bausch & Lomb Monday said it would stop shipping its ReNu with MoistureLoc solution in the United States, but did not issue a recall.

Executives from the eye care company, speaking on a conference call to the investment community, said they cannot predict the sales impact on ReNu with MoistureLoc, which had U.S. sales of roughly $45 million in 2005.

Major retail chains such as Wal-Mart Stores Inc. (Research) and Walgreen Co. (Research) said they were removing the product from store shelves. Walgreen took the added measure of removing all products under the ReNu brand.

"There's a lot of customer confusion out there, which is why we decided to remove the entire ReNu line," a Walgreen spokesman told Reuters.

Shares of Bausch and Lomb (Research) fell 5.3 percent to $46.44 in Wednesday morning trade on the New York Stock Exchange, after touching a three year low Tuesday.

"We have not begun to estimate the ripple effect this will take on other ReNu products," said Ronald Zarrella, the company's chairman and chief executive.

Zarrella told analysts the company will start an aggressive brand-building campaign to help contain the impact of the problems, but the damage may have already be done.

"I think this hurts their brand a great deal," said cornea specialist Dr. David Ritterband of the New York Eye and Ear Infirmary, in a conference call Wednesday sponsored by Banc of America Securities. "I don't know whether they are going to shake it."

The company may already have to mend fences with some of its retail customers. Banc of America analyst David Maris, in a research note, said that the company had indicated Tuesday it had no plans to accept product returns from retailers.

"We predict Bausch & Lomb will reverse this decision in a small attempt to placate an upset trade channel," Maris wrote in a Wednesday report.

10k delays continue
The FDA said Monday it was not aware of a direct link between the infection and any specific product.

But the infection concerns heap new pressure on Bausch & Lomb, which has been plagued by accounting problems. Last month the company said it would delay filing its 2005 annual report by six weeks until around April 30 to make adjustments following internal investigations at foreign subsidiaries.

Zarrella Wednesday said the company would not meet that April deadline, but would not elaborate on the reasons, a move Harris Nesbitt analyst Joanne Wuensch in a research note called "somewhat disconcerting."

She maintained her "neutral" rating on the stock.

"Amidst all the activity around ReNu, the accounting issues continue to be a meaningful risk in our view, and should not be ignored by investors," JP Morgan analyst Michael Weinstein wrote in a research note. He estimated a new filing deadline of May 31.

Concern about an increased incidence of the infection among users of Bausch & Lomb products first arose in Singapore, where authorities linked a number of cases of the infection to ReNu products. Hong Kong officials have asked Bausch & Lomb to pull ReNu from shelves, but the company has said testing has not shown a problem.

Bausch & Lomb said Wednesday the problems in the United States do not affect other markets. There are no reported incidents of fungal eye infections in Europe or China, and the company has been in contact with health authorities in those regions, executives said.

Bausch & Lomb's robust contact lens and lens solution business had helped to double the company's share price since July 2002.

The company last month said the issues with ReNu would reduce first-quarter vision care revenue in the Asia region by as much as $10 million versus internal expectations.

Concerns in Asia have depressed sales in other markets, particularly China, the company has said.

There are more than 35 million contact wears in the United States alone, according to American Academy of Ophthalmology. The physician group is working closely with the FDA and the CDC.