Wednesday, May 10, 2006

More on the Bausch & Lomb contact lense issue

Here is the text of the media release:

For Immediate Release
May 9, 2006
Contact: CDC Media Relations
(404)-639-3286


Fusarium Keratitis Update
The Centers for Disease Control and Prevention (CDC) is continuing its investigation on the multi-state outbreak of Fusarium keratitis that may be associated with contact lens use.

As of May 9, 2006, CDC has received reports of 106 confirmed cases, 12 possible cases and 80 cases still under investigation from 32 U.S. states and territories. 69 reports include insufficient evidence to classify them as cases or carry other non-Fusarium diagnoses. States or territories with at least 1 confirmed or possible case include: AR, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MO, NC, ND, NJ, NY, OH, OK, PA, PR, TN, TX and VT. States where all cases under investigation include: IN, MN, MS, NV, OR and RI.

Not all data are available for all confirmed cases. However, as of May 9, 2006, of the 98 confirmed cases for which CDC has complete data:

5 (5%) did not wear contact lenses (no solution used)
93 (95%) wore contact lenses
59 (63%) reported using any B&L ReNu with MoistureLoc
19 (20%) reported using any B&L ReNu MultiPlus
9 (10%) reported using any unspecified B&L ReNu
3 (3%) reported using any AMO product
4 (4%) reported using any Alcon product
* Some cases reported using more than one type of solution and therefore the solution categories are not mutually exclusive.

(Note: Updated case count numbers will be available on Tuesdays and Fridays. Updated numbers on solution use and other pertinent exposures will be available on Tuesdays.)

Summary and Clarifications
In addition, CDC would like to clarify some of the information that has appeared in a number of recent media stories on the outbreak. The following information is known related to this outbreak:

Since the first report on this outbreak in the April 10, 2006 Morbidity and Mortality Weekly Report (MMWR), CDC has noted that patients have reported using multiple products, including those manufactured by Bausch & Lomb, Alcon, and Advanced Medical Optics, Inc.
At this point, it is too early in the investigation to say whether a particular product or solution may be responsible for the outbreak.
Throughout the investigation, the proportion of patients who reported using Bausch & Lomb's ReNu with MoistureLoc has remained relatively consistent, at around 50-60 percent of confirmed cases.
Since solution bottles were often not available to investigators, reported solution usually reflects patient recall of specific product used during the 30 days before infection. No inferences about causes of infection should be made until additional analyses are completed.
ReNu with MoistureLoc was used by approximately 2.3 million contact lens wearers in the United States, while MultiPlus was used by nearly 11 million contact lens wearers (branded or private label).
Fusarium keratitis is naturally occurring disease in the United States. It is not a disease that healthcare providers must report so it is unclear how many cases occur each year in the United States.
Disease outbreaks and increased media coverage often raise awareness about particular infections, which, in turn, may 1) increase reports of a disease and 2) result in additional information being identified and collected. Thus, it is possible that some of the cases currently being investigated represent infection which might normally occur and, as a result, are not related to the outbreak.
The risk of getting fungal keratitis from contact lenses remains extremely low. Contact lens wearers who experience unusual redness, pain, tearing, light sensitivity, blurry vision, discharge or swelling should consult their doctor immediately.
CDC is continuing its investigation into identifying whether there are specific factors that may have placed people at risk for developing fungal keratitis, including hygiene practices, overnight contact lens wear and specific solutions used. The CDC will provide more information as it becomes available.

For more information on fungal keratitis and advice to doctors and consumers, please visit http://www.cdc.gov/ncidod/dhqp/fungal_fusariumKeratitis.html or http://www.fda.gov/oc/opacom/hottopics/contacts.html.

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