CATARACT/ IOL |
FDA takes a stand ... unapproved ophthalmic irrigating solutions by Maxine Lipner Senior EyeWorld Contributing Editor |
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New regulations mandate changes for some balanced salt solution users  November 24, 2008, began a new chapter for ophthalmic irrigating solutions.
That was the day by which the Food and Drug Administration (FDA) determined
that manufactures needed to stop producing unapproved balanced salt solution.
FDA concerns for ophthalmic safety with the unapproved solutions were
peaked by an outbreak of toxic anterior segment syndrome (TASS), according
to Henry F. Edelhauser, Ph.D., professor of ophthalmology and director
of ophthalmic research, Emory School of Medicine, Atlanta. A study reported in the April 2008 issue of the Journal of Cataract and
Refractive Surgery, highlighted the outbreak of TASS syndrome that occurred
at seven centers from July 19, 2005, through November 28, 2005. Investigators
here determined that of the 112 cases identified, 100 had undergone surgery
with a balanced salt solution manufactured by Cytosol Laboratories (Lenoir,
N.C.). They found that endotoxin limits were exceeded in 35% of the balanced
salt solution lots. Once these products were withdrawn, investigators
noted that the outbreak terminated.
In the recent ruling, the FDA urged users of irrigating solutions to
switch to the approved versions of balanced salt solution such as those
manufactured by Alcon (Fort Worth, Texas) and Akorn (Lake Forest, Ill.).
These approved versions include BSS and BSS Plus surgical solution (Alcon)
and Balanced Salt Solution (Akorn).
The FDA action was taken with patient’s safety in mind, according
to Michael Pfleger, vice president, regulatory affairs, Alcon. “The
FDA’s September 23, 2008 federal register notice stated that the
FDA had received reports of serious safety concerns from users of ophthalmic
balanced salt solution products and that in some instances adverse effects
could be the result of improperly manufactured products,” Mr. Pfleger
said. “Specifically they cited the 2006 example of contamination
with endotoxins of an unapproved balanced salt solution associated with
several hundred reports of adverse events including toxic anterior segment
syndrome.”
Solution basics
Balanced salt solution is a key component of cataract and refractive
surgery, according to Joe Vonderhaar, marketing manager, surgical solutions,
Alcon. “It maintains the shape of the eye, giving the surgeon space
to perform the delicate procedures of cataract removal and vitrectomy,” he
said. “It also provides key nutrients for the tissues during the
surgery.”
The solution is made up of some core ingredients. “Basically it
consists of five salts and a buffer,” Dr. Edelhauser said. Alcon’s
BSS Plus has a couple of extra ingredients as well. “The difference
between BSS and BSS Plus is that BSS Plus has bicarbonate, which is the
natural buffer in the anterior chamber,” Dr. Edelhauser said. “It
also has glutathione which acts as an antioxidant and it has some glucose
in it which provides an energy source.”
The use of balanced salt solutions began simply enough. “The whole
basis of irrigating solutions started with doing extra-cap cataract surgery
because up until that time when they did intra-cap there was only 15
ml’s needed in a little squeeze bottle,” Dr. Edelhauser said. “Then
once they started doing phaco and vitreoretinal surgery there was the
need to make a better intraocular irrigating solution that was compatible
with the intraocular tissues.” Alcon was an early manufacturer
of such solutions and moved to take it to the next level as surgery evolved. “Alcon
was marketing the 15 ml and of course they had to do a number of studies
to gear up to take that to the 500 ml,” Dr. Edelhauser said. The
approval process for BSS Plus involved a lengthy series of studies. “It
took Alcon seven years to get the BSS Plus through the FDA,” Dr.
Edelhauser said. “The reason was that glutathione was considered
a drug.” Meanwhile, off-label solutions were grandfathered in under an FDA clause,
according to Becky Kirkwood, director, cataract marketing for the Americas,
Advanced Medical Optics (AMO, Santa Ana, Calif.). “AMO’s
two balanced salt solution suppliers, B. Braun and Baxter, have been
manufacturing and selling balanced salt solution under the Grandfather
Clause of the Food, Drug and Cosmetic Act as amended in 1962 because
it was generally recognized as safe and effective,” she said. “Balanced
salt solution distributed by AMO is in compliance with section 510 of
the Food Drug and Cosmetic Act as the product is listed with an NDC number
and copies of labeling are submitted to the FDA by our suppliers per
regulation.”
Current impact
In the modern world, balanced salt solutions have become an integral
part of ophthalmic surgery. “None of the (phaco) machines run without
an irrigating solution,” Dr. Edelhauser said. “Then when
you finish your cataract surgery what you leave in the anterior chamber
after you reform the anterior chamber stays there for longer than four
hours.” As a result, practitioners need to be very sure that what
goes into the eye isn’t harmful, he believes.
In Dr. Edelhauser’s view the FDA ruling is helpful to practitioners. “There’s
no doubt that it’s safer,” he said. “Also, I think
that it gives more support to surgery that you’re using FDA approved
products.”
Likewise, Francis S. Mah, M.D., co-medical director, Charles T. Campbell
Ophthalmic Microbiology Laboratory, University of Pittsburgh School of
Medicine, Pittsburgh, sees the ruling as a good one, but is unsure of
its impact. “I think it’s a good move—obviously the
FDA is supposed to be watching out for patients,” he said. “I
would say that probably the majority of surgeons in the United States
were using only approved balanced salt solution, so I would say probably
a minority of U.S. surgeons were impacted.”
Overall, Dr. Mah thinks that the ruling underscores the importance of
using products that have been properly reviewed. “I think that
it reinforces the idea that number one the FDA is doing their job,” he
said. “Number two, it shows that we should be very cognizant of
everything that goes inside of the eye during intraocular surgery.” Editors’ note:
Drs. Edelhauser and Mah have financial interests with Alcon (Fort
Worth, Texas). Contact information: |
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