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Did Compounded Antibiotic-steroid Formulation Cause Cataract Patients' Vision Problems?

So far, as many as 50 cataract patients have reported worsening visual acuity.

Published: April 27, 2017

UNPRECEDENTED "We've never seen a problem like that in the 30 years I've practiced," says ophthalmologist Jeffrey Whitman, MD.

Dozens of patients who underwent routine cataract surgery at a Dallas surgery center during a 22-day stretch earlier this year experienced losses in visual acuity weeks later — ranging from blurred vision to in some cases partial blindness. What could have caused this strange outbreak? Surgeons believe it was a batch of improperly formulated compounded drugs they injected into each patient's eye at the end of surgery.

A pharmacy consultant the ASC called in to investigate quickly determined that:

  • Each of the 30 to 50 patients who developed vision problems received a post-operative injection of an antibiotic-steroid formulation prepared by a local compounding pharmacy that the surgery center had used before, but not for this particular compound.
  • The compounded drug designed to negate the need for post-op eye drops "may not have been compounded to the specifications represented."

Now many of the patients, fearful that they'll never regain their vision, are lining up to sue the compounding lab. Meanwhile, the president of the surgery center is speaking out to warn other surgical facilities to ask compounding pharmacies for certification that they're legally able to make a drug.

PRG Dallas Surgery Center usually received its compounded antibiotic-steroid formulation from Imprimis Pharmaceuticals, a 503B compounding pharmacy that makes a proprietary formulation of the dropless drug called Tri-Moxi and coined the term "dropless cataract surgery." But when Imprimis was unable to supply the surgery center with an adequate supply of Tri-Moxi earlier this year, the ASC turned to Guardian Pharmacy Services, which had supplied the surgery center for years with topical compounded medications.

"We have used Guardian for a long time and have had zero problems," says ophthalmologist Jeffrey Whitman, MD, of PRG.

But Dr. Whitman says he now has reason to believe that the injection was not properly formulated and that Guardian was not authorized to produce Tri-Moxi, a patented drug.

"If you went to the pharmacy and they gave you a medication that wasn't made correctly, you'd be angry. I'm angry as well," says Dr. Whitman. "We've never seen a problem like that in the 30 years I've practiced."

Only patients who were treated at PRG Dallas Surgery Center between Jan. 31 and Feb. 21, 2017, were impacted, says David McCue, an attorney representing the ophthalmology group. "The facts are that up until Jan. 31, [PRG's surgeons] used Tri-Moxi prepared by Imprimis," he says. "They had no problem up until Jan. 31, they had no problem after Feb. 21, and they're not having the problem now.

"We believe the medication that was injected is more likely the problem than not, but the mechanics of how is still to be determined," says Mr. McCue. "Right now we're in an important waiting period. We're looking at a situation where we have 3 categories of people — those who have had no impact to their visual acuity; those who did but seem to be getting better; and a third group that doesn't appear to be getting better."

The ophthalmology practice took immediate action when it discovered the problem, says Mr. McCue, including:

  • discontinuing use of the locally compounded medication;
  • notifying all patients who had cataract surgery in the affected time period and requesting they come in for an examination;
  • referring patients who exhibited symptoms to retinal specialists for no-cost treatment;
  • notifying all surgeons at the PRG Surgery Center who used the locally compounded medication so they could alert their patients; and
  • setting up a hotline to provide patients with support.

"We created all the media coverage," says Dr. Whitman. "We wanted to get out in front of this and let other surgery centers know that this was out there."

A 55-year-old truck driver named Curtis Cosby started developing complications in the days following his cataract surgery, his vision has continued to deteriorate, says Andrew Sommerman, Mr. Cosby's attorney.

"He's been a truck driver all his life, and he can't do that anymore," says Mr. Sommerman. "His other eye has cataracts, but he can't even think about that right now. If he had gone without having his cataracts treated, he probably would have been able to continue driving for several years."

Besides Mr. Crosby, Mr. Sommerman has 5 more clients who claim to report vision loss as a result of their treatment, and 10 more prospective clients have reached him complaining of similar complications. He has reason to believe the medication may have affected as many as 30 to 50 people, including those treated at other surgical facilities during the same time period.

Outpatient Surgery Magazine attempted to reach a representative from Guardian for comment but did not receive a response. In a televised news report, Guardian founder and president Jack Munn, RPh, said in a statement, "A lab analysis is underway. We cannot make a comment yet."

Bill Donahue


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