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

Posted 4 Oct 2017 by Drugs.com

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 ... Read more

Related support groups: Cataract, Vigamox, Triesence, Moxeza, Trivaris

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

Posted 31 Jul 2017 by Drugs.com

[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. 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 en ... Read more

Related support groups: Vigamox, Ophthalmic Surgery, Triesence, Moxeza, Trivaris

FDA Bolsters Warnings About Class of Antibiotics

Posted 26 Jul 2016 by Drugs.com

TUESDAY, July 26, 2016 – The U.S. Food and Drug Administration announced Tuesday that it's strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons. The agency also cautioned that these bacteria-fighting drugs – including levofloxacin (Levaquin) and ciprofloxacin (Cipro) – shouldn't be prescribed for sinusitis, chronic bronchitis or simple urinary tract infections unless no other treatments options exist. "Fluoroquinolones have risks and benefits that should be considered very carefully," Dr. Edward Cox said in an FDA news release. He's director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research. "It's important that both health care providers and patients are aware of both the risks and benefits of ... Read more

Related support groups: Infections, Urinary Tract Infection, Peripheral Neuropathy, Sinusitis, Bladder Infection, Cipro, Bronchitis, Ciprofloxacin, Levaquin, Levofloxacin, Kidney Infections, Myasthenia Gravis, Avelox, Ofloxacin, Vigamox, Ciprodex, Sinus Symptoms, Moxifloxacin, Norfloxacin, Gatifloxacin

Eye Antibiotics Can Cause Drug-Resistant Bacteria: Study

Posted 12 Sep 2011 by Drugs.com

MONDAY, Sept. 12 – Repeated use of antibiotics among patients who receive eye injections for such ophthalmic conditions as age-related macular degeneration can lead to the emergence of drug-resistant germs, according to a new study. More than eight million people in the United States are affected by age-related macular degeneration, and its treatment involves monthly injections that are typically followed by antibiotics to prevent such complications as inflammation of the eye. Researchers from Vanderbilt University School of Medicine in Nashville found, however, that long-term use of antibiotics after eye injection therapy may promote the growth of hard-to-treat germs. "Repeated exposure of ocular flora [microbes living on or inside the body] ... may select for resistant bacterial strains and cultivate 'superbugs' with multiple-drug resistance ..." the study's authors wrote a news ... Read more

Related support groups: Macular Degeneration, Vigamox, Povidone Iodine, Sulfacetamide Sodium, Stye, Zymar, Azasite, Boric Acid, Polytrim, Lucentis, Tobrex, Polymyxin B/Trimethoprim, Silver Nitrate, Trifluridine, Besivance, Neosporin Ophthalmic, Ocuflox, Natacyn, Zirgan, Zymaxid

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