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Triesence FDA Alerts

The FDA Alerts below may be specifically about Triesence or relate to a group or class of drugs which include Triesence.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Triesence

Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

Oct 3, 2017 | Audience: Opthalmology, Pharmacy

ISSUE: FDA received an adverse event report on August 14, 2017, from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV) after being administered injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye at the conclusion of cataract surgery procedures that were done two weeks apart. The TMV formulation was compounded by Imprimis Pharmaceuticals, Inc., located in Ledgewood, New Jersey.

HORV is a rare, potentially blinding postoperative complication that has been observed in dozens of patients who have received intraocular injections of vancomycin (anti-infective) formulations toward the end of otherwise uncomplicated cataract surgeries.

BACKGROUND: Many ophthalmologists use intraocular vancomycin during cataract surgery with the intent of preventing postoperative endophthalmitis. FDA is unaware of any adequately controlled studies demonstrating the safety and efficacy of intraocular vancomycin in preventing endophthalmitis. There is no FDA-approved vancomycin formulation for intraocular injection. The formulation is usually prepared at the surgical site or obtained in advance of surgery from a compounding pharmacy.

The use of intraocular vancomycin has recently been associated with the newly described condition HORV. Characteristics of HORV include a delayed onset (up to three weeks) of sudden painless decreased vision, intraocular inflammation, intraretinal hemorrhage (bleeding within the retina), retinal vasculitis (inflammation within retinal vessels), vascular occlusion (blockage of retinal vessels), and retinal ischemia (lack of sufficient blood supply to the retina). If vancomycin is administered to both eyes, legal blindness is a likely consequence of HORV.

No cases of HORV were reported in a retrospective analysis of medical records of 922 patients (1541 eyes) who underwent cataract surgeries with intravitreal injections of compounded TMV formulations from November 2013 to December 2015. However, this chart review of non-controlled data is limited in its ability to identify rare events and may not necessarily be generalizable to a larger population who may undergo cataract surgery. The adverse event being reported here serves as a reminder that intraocular administration of vancomycin, including when the vancomycin is one of multiple active ingredients in a compounded drug, can result in HORV.

RECOMMENDATION: The prophylactic use of intraocular vancomycin, alone or in a compounded drug combining multiple active ingredients, during cataract surgery is generally not recommended because of the risk of HORV.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[10/03/2017 - Statement - FDA]

Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported

Jul 28, 2017 | Audience: Ophthalmology, Pharmacy, Patient

[Posted 07/28/2017]

ISSUE: FDA received adverse event reports on April 5 and June 1, 2017, concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients were administered Guardian’s product at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center in Dallas, Texas, by physicians affiliated with the Key Whitman Eye Center, and at the Park Central Surgical Center in Dallas, Texas, by physicians affiliated with Tylock-George Eye Care. Note - Guardian Pharmacy Services in Dallas is not affiliated with the national long-term care Guardian Pharmacy Services headquartered in Atlanta.

According to information received from Park Central, Guardian’s product was injected into the vitreous of the eye at the end of the cataract surgery procedure. The purpose of the injection was to provide post-operative prophylaxis for ocular inflammation and endophthalmitis with the expectation that the patient would not need to use post-operative eye drops. Over the course of several months, patients developed 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. A number of the symptoms were not exhibited until at least one month postoperatively.

During follow-up examinations of the Park Central patients, physicians observed that the patients had diminished visual function involving both visual acuity and visual fields. Optical coherence tomography testing initially showed macular edema (swelling), which was followed in some cases by retinal degeneration. While the symptoms reportedly improved in some patients over the five-month post-operative period, a number of patients remain with a significant reduction in best-corrected visual acuity and visual fields.

BACKGROUND: Compounded drugs are not reviewed by FDA for safety, effectiveness, or quality.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[07/28/2017 - Alert to Health Professionals - FDA]

Franck's Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall

May 24, 2012 | Audience: Ophthalmology, Urology, Primary Care, Pharmacy

 

[Posted 05/24/2012]

ISSUE: FDA is notifying all physicians and medical care organizations who have ordered any compounded product sold as a sterile preparation by Franck's Compounding Pharmacy of Ocala, Florida, of the recall of all sterile products sold by Franck's since November 2011 due to the possibility of lack of sterility.

BACKGROUND: The recall is being carried out to the user/physician level. An active investigation of this matter by the CDC and FDA is ongoing at this time. In March 2012, FDA received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck's Pharmacy, during eye surgeries. Clinicians in several states reported the adverse events. In April 2012, FDA received reports of eye infections in patients who were given injections of Franck’s drug products containing triamcinolone during eye surgery.

RECOMMENDATIONS: FDA advises that any product received from Franck's since November 2011 not be used and customer/physicians follow the instructions provided by Franck’s. FDA also recommends that any adverse events suspected to be associated with use of the products be reported to FDA:


[05/24/2012 - Press Release - Franck's Compounding Pharmacy]
[05/04/2012 - MMWR Weekly Report - CDC]

Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases

Apr 20, 2012 | Audience: Ophthalmology, Risk Manager

 

[UPDATED 04/20/2012] FDA issues second warning to physicians regarding cvertain compounded drugs from Franck's. FDA received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

 

[Posted 03/19/2012]

ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck's Pharmacy, during eye surgeries. Clinicians in several states reported the adverse events. FDA, along with CDC and local and state public health agencies, are actively investigating these adverse events.

BACKGROUND: The BBG was supplied by Franck’s Compounding Lab, Ocala, Florida. Franck’s Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter (link below). Brilliant Blue G is not an approved drug in the U.S. 

RECOMMENDATION: Immediately quarantine and return any remaining Brilliant Blue G product from Franck’s Compounding Lab. This includes all lots of Brilliant Blue G received from Franck’s.

FDA requests that practitioners report to MedWatch any cases of endophthalmitis, fungal or bacterial, that occurred within the last six months, associated with eye surgery in which Brilliant Blue G from any source was used.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[04/20/2012 - Warning to Physicians - FDA]

[03/19/2012 - Warning Statement - FDA]
[03/09/2012 - Recall Letter - Franck’s Pharmacy] 

Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians

Apr 20, 2012 | Audience: Eye Care, Family Practice, Pharmacy
  • Brilliant Blue G (BBG)
  • Triamcinolone

 

[Posted 04/20/2012]

ISSUE: FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012. The agency has also recently received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

BACKGROUND: Clinicians in several states reported the adverse events. FDA, CDC, and local and state public health agencies are actively investigating these incidents.

These drugs were supplied by Franck’s Pharmacy in Ocala, Florida. Brilliant Blue G is not an approved drug in the United States. Franck’s has recalled all lots of BBG and one lot of Triamcinolone Acetonide P.F

RECOMMENDATION: The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to stop use of all sterile triamcinolone-containing products purchased from Franck’s until further information regarding the safety of these products is available.

FDA requests that practitioners report to FDA any cases of suspected fungal or bacterial infections, which have occurred within the last six months, associated with drugs labeled as sterile from Franck’s Pharmacy:

 

[04/20/2012 - Updated Warning - FDA]
[03/31/2012 - Press Release - Franck’s Compounding Lab]

Previous MedWatch Safety Alert

[03/19/2012]

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