Case of HORV reported after intraocular Inj of a compounded triamcinolone, moxifloxacin, vancomycin

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

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 ...

Recommended for you

  • MedWatch Drug Updates
  • 1 comment

FDA update: Type III endoleaks associated with the use of endovascular graft systems

  • MedWatch Drug Updates
  • 1 comment

FDA update: High risk of mortality and neurological adverse events when using SynCardia's TAH-t C2 Driver System

  • MedWatch Drug Updates
  • 1 comment

Class I Recall of Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Blocked guidewire lumen

  • MedWatch Drug Updates
  • 1 comment

Recall of Intralipid 20 % IV Fat Emulsion by Baxter: One lot of product exposed to subfreezing temperature

  • FDA Drug Updates
  • 1 comment

FDA approved Aliqopa (copanlisib) for the treatment of relapsed follicular lymphoma

  • FDA Drug Updates
  • 1 comment

FDA approved Mvasi (bevacizumab-awwb) for the treatment of cancer

  • MedWatch Drug Updates
  • 1 comment

Case of HORV reported after intraocular Inj of a compounded triamcinolone, moxifloxacin, vancomycin

  • MedWatch Drug Updates
  • no comment

FDA alert- Not to use infant sleep positioners as it can cause suffocation

  • MedWatch Drug Updates
  • 1 comment

FDA recommends separate dosing for Kayexalate (sodium polystyrene sulfonate) from all other oral drugs

  • MedWatch Drug Updates
  • no comment

Class I Recall of Intra-Aortic Balloon Pump by Datascope/MAQUET- False blood detection alarm and ingress of fluid into the pump

  • MedWatch Drug Updates
  • 1 comment

FDA statement on risks of unapproved use of Keytruda (pembrolizumab) for treatment of multiple myeloma

  • MedWatch Drug Updates
  • 1 comment

Recall of Piyanping Anti-Itch Lotion by Lucky Mart Inc.: Contain wrong active pharmaceutical ingredient

  • FDA Drug Updates
  • 1 comment

FDA approves Besponsa (inotuzumab ozogamicin) for acute lymphoblastic leukemia

  • MedWatch Drug Updates
  • 1 comment

FDA alert: Incorrect dosing of Ocaliva (obeticholic acid) associated with increased risk of serious liver injury

  • MedWatch Drug Updates
  • 1 comment

FDA advise on use of opioid addiction medication in patients taking benzodiazipines or CNS depressants

  • FDA Drug Updates
  • 1 comment

New targeted treatment approved for relapsed or refractory acute myeloid leukemia

  • MedWatch Drug Updates
  • 1 comment

Class I recall of Penumbra 3D Revascularization device by Penumbra: delivery wire may break or separate during use

  • FDA Drug Updates
  • 1 comment

FDA approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Hepatitis C

  • MedWatch Drug Updates
  • 1 comment

Recall of VV28F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical- Extension tube may separate from hub

  • FDA Drug Updates
  • no comment

FDA approved Nerlynx (neratinib) for breast cancer

  • MedWatch Drug Updates
  • 1 comment

Recall of Diabetes Infusion Sets by Medtronic -Vent Membrane susceptible to blocking by fluid

  • MedWatch Drug Updates
  • 1 comment

Recall of Baby Organic Liquid Formula by Garden of Life: Misleading direction for use

  • FDA Drug Updates
  • no comment

FDA approved Endari (L-glutamine) for sickle cell disease

  • MedWatch Drug Updates
  • 1 comment

Recall of Novopen Echo Insulin Delivery Device by Novo Nordisk: Chemical exposure may damage cartridge holder

  • MedWatch Drug Updates
  • 1 comment

Recall of Atar Extension Cables by Oscor- cable malfunction interrupting the pacing system

  • MedWatch Drug Updates
  • 1 comment

Recall of Activase (alteplase) 100mg by Genentech due to lack of sterility assurance

  • FDA Drug Updates
  • 1 comment

FDA approved Haegarda (C1 esterase inhibitor) for Hereditary Angioedema

  • MedWatch Drug Updates
  • 1 comment

Recall of Oxytocin compounded with either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium

  • MedWatch Drug Updates
  • 1 comment

FDA Alert- Not to use Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products

  • MedWatch Drug Updates
  • 1 comment

Field Correction of system CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope