By Steven DiJosephBausch & Lomb has always been regarded as a reputable consumer-product company specializing in eye health and perfecting vision. During its 153-year history, the Rochester, New York, the company has gradually become a highly visible and respected healthcare brand worldwide with annual revenues of over $2 billion from sales in over 100 countries where it employs some 13,700 people.

The company’s product line has changed over the years as eye care has advanced. Currently its core businesses include soft and rigid gas permeable contact lenses, lens care products, and ophthalmic surgical and pharmaceutical products.

Thus, it has come as somewhat of a shock to industry experts and consumer advocates that Bausch & Lomb has found itself in the middle of a rapidly-growing controversy concerning the safety of one of its widely used contact lens solutions, ReNu with MoistureLoc,

The difficulties have seriously affected Bausch & Lomb’s stock value. Shares of the company’s stock dropped 17.3% on the day after it voluntarily suspended shipments of the affected product.

The company had enjoyed two years of rapid growth in which its stock peaked at $87.89 in July, 2005. By this week, however, the stock had hit a two-year low of $47.50. Analysts cut their ratings on the shares amidst concerns that the recall could have a significant impact on sales of the company’s other products.

Bausch & Lomb had recently (March 17) had to deal with a number of accounting problems that resulted in the company having to reduce its reported net sales by a combined $9.3 million after an internal investigation determined its South Korean subsidiary had engaged in improper sales practices between 2002 and 2005.

In December 2005, the company moved to restate financial results back to 2001 because of accounting irregularities at its Brazilian unit. Only last month, several class-action lawsuits were filed against the company alleging insider trading in connection with the investigations.

The company’s current product-related troubles are twofold; what is causing the problem, and why does there appear to have been a failure to take immediate corrective action in terms of a recall or warning?

As we previously reported, the warnings issued by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been serious and to the point:

“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.”

So far, 109 cases of the infection have been reported to the CDC from 17 states in the U.S. Of 30 cases already investigated, 28 involved soft contact lens wearers and 26 of those patients had used Bausch & Lomb’s ReNu or a generic version thereof also produced by the company. Most of those cases involved ReNu with MoistureLoc produced at the company’s Greenville, South Carolina, plant.

While the bulk of the investigated cases are linked to ReNu, other solutions were used by some of the infected patients thereby raising the possibility that other products may also be involved.

Nine patients reported wearing their lenses overnight, “a known risk factor for microbial keratitis”, and eight required corneal transplantation.

The FDA is also advising soft contact lens wearers to follow all instructions and preventive hygiene practices carefully.

The Preliminary Public Health Notification issued by the FDA also contains the following additional information:

“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.

“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%.”

A newly filed class-action alleges Bausch & Lomb failed to disclose the possible link between ReNu with MoistureLoc and Fusarium keratitis once it learned of the problem among its users in Asia. Singapore health officials noticed an increase in reports of infection in January of this year. An investigation revealed 39 cases involving contact lens users from 2005 to February 2006. Cases of the infection have also been reported in Malaysia and Hong Kong.

As the investigation continues with the company’s cooperation, the FDA offers the following 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, the agency recommends:

• 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.

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

In an effort to gather as much information as possible relating to fungal keratitis in contact lens users the FDA and CDC “encourage you to report these infections to FDA. FDA will be sharing reported information with CDC.”

Reports can be made directly to MedWatch, the FDA’s voluntary reporting program by telephone 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.

Those reporting information on fungal keratitis should include the following information if possible:

• 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).

This entry was posted on Friday, April 14th, 2006 at 9:11 am and is filed under Health Concerns, Legal News.