Serious ADRs with ocular triamcinolone/moxifloxacin product

Serious ADRs with ocular triamcinolone/moxifloxacin product Reactions 1664, p4 - 12 Aug 2017 Serious ADRs with ocular triamcinolone/moxifloxacin product A compounded drug product containing triamcinolone (i.e. steroid) and moxifloxacin (i.e. anti- infective) is associated with serious ADRs, according to a US FDA Safety Alert. This product – which is compounded by Guardian Pharmacy Services (Dallas, Texas) – is intended for intravitreal injection following cataract surgery for postoperative prophylaxis of ocular inflammation and endophthalmitis; the expectation is that the patient would not require postoperative eye drops. The FDA received adverse event (AE) reports on 5 April and 1 June this year relating to at least 43 patients who had received intravitreal injections of the above- mentioned triamcinolone/moxifloxacin product following cataract surgery, which was performed at two different surgery centres in Dallas. Several months after their operations, these patients developed a variety of symptoms, including: vision impairment, poor night vision, loss of colour perception, photophobia, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea. Some of these AEs mentioned did not occur until at least 1 month following the cataract surgery. During follow-up examinations of patients treated at the Park Central Surgical Center, physicians found that patients who received the triamcinolone/moxifloxacin product experienced decreased visual function that involved visual acuity and visual fields. Initial optical tests revealed macular oedema, followed by some cases of retinal degeneration. During the 5-month postoperative period, some patients reported symptom improvements, but a number of patients continued to experience "a significant reduction in best-corrected visual acuity and visual fields", stated the FDA. Both patients and healthcare professionals are encouraged to report AEs related to this compounded triamcinolone/moxifloxacin product to the FDA’s MedWatch programme. US Food and Drug Administration. Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported. Internet Document : 28 Jul 2017. Available from: URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm569123.htm 803263660 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Serious ADRs with ocular triamcinolone/moxifloxacin product

Reactions Weekly , Volume 1664 (1) – Aug 12, 2017
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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-34284-1
Publisher site
See Article on Publisher Site

Abstract

Reactions 1664, p4 - 12 Aug 2017 Serious ADRs with ocular triamcinolone/moxifloxacin product A compounded drug product containing triamcinolone (i.e. steroid) and moxifloxacin (i.e. anti- infective) is associated with serious ADRs, according to a US FDA Safety Alert. This product – which is compounded by Guardian Pharmacy Services (Dallas, Texas) – is intended for intravitreal injection following cataract surgery for postoperative prophylaxis of ocular inflammation and endophthalmitis; the expectation is that the patient would not require postoperative eye drops. The FDA received adverse event (AE) reports on 5 April and 1 June this year relating to at least 43 patients who had received intravitreal injections of the above- mentioned triamcinolone/moxifloxacin product following cataract surgery, which was performed at two different surgery centres in Dallas. Several months after their operations, these patients developed a variety of symptoms, including: vision impairment, poor night vision, loss of colour perception, photophobia, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea. Some of these AEs mentioned did not occur until at least 1 month following the cataract surgery. During follow-up examinations of patients treated at the Park Central Surgical Center, physicians found that patients who received the triamcinolone/moxifloxacin product experienced decreased visual function that involved visual acuity and visual fields. Initial optical tests revealed macular oedema, followed by some cases of retinal degeneration. During the 5-month postoperative period, some patients reported symptom improvements, but a number of patients continued to experience "a significant reduction in best-corrected visual acuity and visual fields", stated the FDA. Both patients and healthcare professionals are encouraged to report AEs related to this compounded triamcinolone/moxifloxacin product to the FDA’s MedWatch programme. US Food and Drug Administration. Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported. Internet Document : 28 Jul 2017. Available from: URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm569123.htm 803263660 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664

Journal

Reactions WeeklySpringer Journals

Published: Aug 12, 2017

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