[OEM] FDA/ProMED: Local Toxic Response to Ophth-drop Endotoxin Contamination (fwd)

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ENDOTOXINS, OPHTHALMIC SOLUTION - USA: RECALL

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A ProMED-mail post <http://www.promedmail.org>

ProMED-mail is a program of the International Society for Infectious Diseases

<http://www.isid.org>

Date: Mon, 13 Feb 2006 [ProMED regrets the delay in posting]

Source: FDA.gov [edited]

<http://www.fda.gov/bbs/topics/news/2006/NEW01315.html>

The FDA today, 13 Feb 2006, delivered a letter to Cytosol

Laboratories, Inc., of Braintree, MA, to request a recall of all

brands and sizes of Balanced Salt Solution (BSS) that the firm

manufactures. BSS is a solution used by health professionals to

irrigate a patient's eyes, ears, nose and/or throat during a variety

of surgical procedures including cataract surgery.

FDA requested the recall because product lots were found to have

elevated levels of endotoxin. Endotoxins, also known as pyrogens, are

substances found in certain bacteria that cause a wide variety of

serious reactions such as fever, shock, changes in blood pressure and

in other circulatory functions. FDA has received reports of a serious

and potentially irreversible eye injury called Toxic Anterior Segment

Syndrome (TASS) which occurs when a contaminant, such as endotoxin,

enters the anterior segment of the eye during surgery and causes an

inflammatory reaction. FDA has also received complaints relating to

injuries in over 300 patients who were given BSS manufactured by

Cytosol Laboratories, Inc.

The FDA requests that the company take immediate action to retrieve

all inventories of the product, including any existing stock at

physician offices and hospitals. An FDA-requested recall is initiated

to protect the public health when a product that has been distributed

represents a risk of illness or injury and the firm has not initiated

a recall of the product. FDA is instructing hospitals, physicians, and

consumers to immediately stop using any of these products, quarantine

any remaining product, and if no return instructions from Cytosol are

received, destroy the product.

An estimated 1 million units of BSS products were distributed between

Dec 2003 and Dec 2005. The BSS products subject to the recall order

were manufactured by Cytosol Laboratories, Inc. for distribution under

3 labels:

" AMO Endosol " distributed by Advanced Medical Optics, Inc. (AMO),

Santa Ana, Calif.;

" Cytosol Ophthalmics " distributed by Cytosol Ophthalmics, Lenoir, NC; and

" Akorn " distributed by Akorn, Inc., Buffalo Grove, Ill.

- -- ProMED-mail <promed@...>

[Toxin anterior segment syndrome is not an entity previously discussed

on ProMED. The following is a discussion on TASS and its

differentiation from infectious endopthalmitis:

<http://www.aao.org/aao/news/eyenet/cataract/cataract_nov.htm>:

It is important to differentiate TASS from true infectious

endophthalmitis, because the treatments are completely different --

and the treatment for one isn't appropriate for the other. Symptoms

for the 2 conditions may overlap, making diagnosis difficult. In fact,

surgeons often initially treat TASS as infectious endophthalmitis.

Here are some pointers for separating the 2:

- -Early onset: TASS usually is seen soon after surgery -- later the

same day or the next. Infectious endophthalmitis, in contrast, most

commonly shows up 3 to 4 days postoperatively.

- - Corneal edema: with TASS, patients complain of pain and blurred

vision, and the biggest hallmark is profound limbus-to-limbus corneal

edema. The limbus is the edge between the cornea and the sclera (the

white part of the eye). Some edema will occur with endophthalmitis,

but typically not diffuse limbus- to-limbus corneal edema. Edema after

surgery is specific to areas of trauma, so it tends to be near the

wound or opposite the wound, but some areas are not affected; not so

with TASS.

- - Inflammation: on ophthalmological examination, TASS patients have

a marked increase in inflammation in the anterior segment. An

increased in the number of white blood cells and sometimes even a

hypopyon (pus on the anterior chamber of the eye between the cornea

and the iris) can be seen.

- - Fixed pupil: TASS impairs the iris sphincter function, and the

pupil tends to be fairly dilated and does not react well to light.

- - High intraorbital pressure (IOP): TASS also affects the trabecular

meshwork, a network of fibers involved in the drainage of the aqueous

humor of the eye and located at the iridocorneal angle between the

anterior chamber of the eye and the venous sinus of the sclera. In

endophthalmitis, IOP usually is not elevated. A pressure of 40-70 mmHg

is much more likely with TASS.

In a toxic reaction such as TASS, the inflammation will stabilize or

even get slightly better a few hours later. If it is infectious, signs

will get a little worse. If any hint that an infectious process is

occurring early, vitreous fluid aspiration and culture should be

immediately done and antibiotics begun. If it is TASS, the patient

should be treated with a topical corticosteroid every hour and a

nonsteroidal 4 times a day.

At 1 to 3 weeks, TASS may still appear inflamed, but the eye still may

recover nicely if treated properly. If it still looks significantly

inflamed at 6 weeks, however, further improvement is not likely to

occur.

Severe TASS can cause substantial damage such as permanent damage to

the corneal endothelium; profound cystoid nonresolving macular edema;

a permanently dilated fixed pupil; and permanent damage to the

trabecular meshwork, leading to resistant glaucoma that requires

multiple surgical procedures. Milder cases of TASS get better in a

couple of weeks without treatment, so it is likely that cases are

missed. - Mod.LL]