The FDA has issued an urgent alert for two eye drugs made by Guardian Pharmacy Services, a Texas based compounding pharmacy. The drugs are compounded Triamicinolone and Moxifloxacin. According to the FDA, serious adverse effects have been reported, including some suggestion of permanent vision loss. Both drugs were made to be injected into a patient’s eye.
Since April of this year, at least 43 patients have reported “adverse events” after being injected by the drugs. An “adverse event” is bureaucratic speak for injury or bad side effect. All of the drugs at issue were made by Guardian Pharmacy Services of Dallas, Texas.
Triamcinolone (also spelled as triamicinalone) is a steroid while moxifloxin is used to fight infections. The drugs are often administered to cataract patients post surgery.
All of the adverse reports pertain to drugs administered at the PRG Dallas Ambulatory Surgery Center in Dallas and at the Park Central Surgical Center. Both facilities are located in Dallas. The physicians reporting the adverse events are affiliated with Key Whitman Eye Center and Tylock-George Eye Care.
The injections are often given so that patients will not need post-operative eye drops. Absent an allergic reaction, the drugs are considered safe. In fact, cataract procedures today are overall considered quite safe. That 43 people would suffer form severe reactions in such a short time period suggests a problem with the sterility of the products or contamination in the manufacturing process.
The FDA says that patients receiving the Guardian Pharmacy Services medications reported “various symptoms, including vision impairment (blurred or decreased vision), poor night vision, loss of color perception, photophobia (light sensitivity), glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea.”
What makes this safety alert particularly concerning is that a number of the symptoms were not exhibited until at least one month postoperatively.
Worse, the problem has persisted for some patients for months and in a few patients, there are signs of retinal degeneration. If not corrected, those patients could become blind. Some patients are reporting a significant reduction [in] visual acuity and visual fields.
Compounding Pharmacies Exempt from Many Regulations
The FDA inspects thousands of drug manufacturing facilities worldwide. Inspection standards and quality assurance tolerances are quite strict. Unfortunately, compounding pharmacies are largely outside the purview of the FDA. Regulation and inspection is often left to individual state pharmacy boards. Many of those boards, however, lack the personnel or training to inspect pharmaceutical manufacturing facilities.
Despite not being the subject of all FDA cGMP (current good manufacturing practices) regulations, the FDA inspected the facility last October. Investigators found many problems including sterilization issues, record keeping and inadequate manufacturing space “for the orderly placement of equipment and materials to prevent mix-ups between drug products and to prevent contamination.”
In 2014, we wrote about the New England Compounding Center in Framingham, Massachusetts. Federal agents raided that facility and arrested 14 people. The Justice Department says that compounding pharmacy was making and distributing contaminated drugs made with expired ingredients and produced in squalid conditions. As many as 64 people were killed by those drugs which allegedly caused a deadly outbreak of fungal meningitis.
Two Separate Guardian Pharmacy Services in Texas?
Guardian Pharmacy Services and its affiliate Guardian Pharmacy of Dallas – Fort Worth claim they are not related to the company of the same name and also located in Dallas, Guardian Pharmacy Services, LLC. Guardian’s website says:
“An unrelated compounding pharmacy in Dallas, Texas, doing business as Guardian Pharmacy Services, LLC, was recently in the news. We want to clarify that our company and our partner, Guardian Pharmacy of Dallas-Fort Worth, is not and has never been associated with this pharmacy.”
Why the Delay in the FDA Alert?
The Dallas Morning News reported this story in April. In fact, the FDA notes that it received its first report on April 5th. Normally the FDA disseminates information about adverse drug events immediately. We suspect the FDA had already identified which local physician groups were using the compounded Triamcinolone and Moxifloxacin and was already in contact with all parties. It appears that the State of Texas blocked all sales of the allegedly compromised drugs in April.
Seeking Patients and Whistleblowers
We hope the 43 incidents are not the tip of the iceberg. The delayed onset of symptoms concerns us. Others may have been injured and not even know it yet. In our experience, when a pharmaceutical manufacturing facility is using nonsterile equipment or operating in a contaminated environment, other drugs may also be compromised, contaminated or adulterated.
The Dallas Morning News feature tells the stories of several victims of the allegedly compromised injections. Their stories are tragic. Some patients are slowly witnessing their vision disappearing day by day.
Thus far, none of the doctors have determined how to help those folks most affected by the injections.
We are currently investigating when the surgery centers that performed the cataract procedures first learned of the problem and what steps were taken to both report the problem and prevent future occurrences. We obviously want to know everything that transpired within Guardian Pharmacy Services after their last FDA inspection. What did the executives know? When did they know? What actions did they take to fix conditions after the first inspection? Why didn’t they report any problems? What did the chief pharmacist know?
We find it difficult to believe that this situation went on for months before action was taken.
Under the Texas and federal False Claims Act, whistleblowers with inside information about healthcare fraud can claim significant awards for their information. Obviously we also want to insure that these problems never happen again.
Will there be an award in this case? There could be if any of the surgeries were covered by Medicare or Medicaid.
Patients also have rights. Whether or not Guardian Pharmacy Services was guilty or not, the physicians performing the surgeries and the facilities where the surgeries took place had a duty to investigate and take action when patients began complaining of problems. The events reported by patients are not ordinary for cataract surgery.
Pharmacists and workers in other compounding pharmacies are also invited to contact us. We want to help you protect patients, stamp out fraud and contaminated drugs and earn you the maximum award possible. (Please see our pharma whistleblower page for more information.)