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Happy New Year OAS Members!
We are eagerly looking forward to an exciting 2024, starting with our Annual Meeting February 9-10 in Houston with the addition of an Ophthalmic Block Workshop on February 11th.
Hot Topics and Speakers for Next Month!
-International Mission Work with Ophthalmology
David Markoff, MD
-Pediatric Anesthesia- Clinical Tools for the Everyday Practitioner
Neil Masters, MD
-International Speakers
Adrian Kwa, MD, Nottingham University Hospitals NHS Trust, UK
Iosifina Giannakikou, MD, Hygeia Hospital, Greece
Lakshmi Prasanna Srinivasan, MD, Sankara Nethralaya, India
-Incision Free eye Blocks- American Approach
Howard Palte, MD, University of Miami
And more!
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Workshop Overview:
Orbital Anatomy
Randy Harvey, BS, RRT, APRN, CRNA, FAANA, Orbital Compliance Group
Ophthalmic blocks
Randy Harvey, BS, RRT, APRN, CRNA, FAANA, Orbital Compliance Group
Simulation Training
Randy Harvey, BS, RRT, APRN, CRNA, FAANA, Orbital Compliance Group
Adrian Kwa, MD, Nottingham University Hospitals NHS Trust, UK
Matthew Springer, DNAP, CRNA, Lincoln Surgical Hospital
Whether you are an anesthesiologist, CRNA, ophthalmologist, nurse, resident or student, there is something for everyone at the OAS Annual Scientific Meeting.
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Topic: Recent FDA Warning to Enhance Patient Awareness of Unapproved Eye Treatments
Authors:
Momin, Sibtainzehra MD MPH
Yerabolu, Krishin Undergraduate Student
Singh, Vinodkumar MD
University of Alabama at Birmingham
Birmingham VA Medical Center, Birmingham, AL
Introduction:
The U.S. Food and Drug Administration (FDA) has issued a stern warning indicating that eight companies are not in compliance with FDA regulations. This pertained to unapproved eye products being sold without adequate regulatory oversight. These products, which include various eye drops and ointments, pose a significant risk to consumers’ eye health. In this article, we will delve into this warning and why it’s crucial to be cautious while choosing eye products.
The FDA Warning:
In recent years, there has been a growing concern regarding the safety and efficacy of eye medications marketed to the common consumer. The FDA from time to time issues warning letters to inform the public of medications that could potentially harm instead of helping cure the problem at hand.
On September 12th, the FDA issued a letter stating that Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/ Similasan USA, TRP Company Inc., and Walgreens Boots Alliance Inc. were all not in compliance with the regulations (Administration, 2023). Moreover, the FDA issued an urgent warning, emphasizing the vital need to remove all products linked to the claim within a strict 15 day timeframe. This pertains to a range of eye drops, ointments, and similar products that are being marketed and sold without the agency’s approval. The warning highlights several key concerns:
- 1. Lack of efficacy data: Unapproved eye products may not have undergone rigorous testing for efficacy, meaning there’s no guarantee they will work as intended.
- 2. Safety concerns: These products may contain ingredients that can cause irritation, allergies, or other adverse effects on the eyes, potentially leading to vision problems.
- 3. Quality control issues: Unregulated manufacturing processes can result in inconsistent product quality and contamination risks.
- 4. False claims: Some unapproved products make unfounded claims about their ability to treat various eye conditions, misleading consumers.
This poses a serious concern as the US Ophthalmic drug market continues to rise and individuals are put at risk every day due to drug companies not making medication safe to use (Figure 1).
Figure 1: Research done by Grand View research shows that the US Ophthalmic drug market continues to increase in market share. The jump from 2021 to 2022 shows a 113% percent increase and decade trajectories indicate the market share will continue to increase (Region, 2022).
Why the Warning Matters:
The human eye is a delicate organ, and using unapproved and potentially unsafe products can have serious consequences. For example, these eye drops/ointments may contain silver, and long-term usage of silver has been shown in literature reports to cause necrosis of conjunctival epithelia cells, argyria, irritation, corneal opacity, and symblepharon (Waszczykowska et al., 2021). It is imperative to understand that FDA approval is not a mere formality but a rigorous evaluation of products’ safety and efficacy. Unapproved products bypass this step, leaving consumers vulnerable to potentially harmful consequences. For this reason, the FDA has stated that legal action will be pursued if the claims are not addressed by the companies. FDA Director of Compliance Jill Furman ensures that the FDA continues to work hard to ensure that the unapproved eye medications are removed from the market to foster greater patient safety.
Protecting the Patients:
To safeguard your patients, consider:
- 1. Check FDA Approval: Always look for FDA approval on the packaging of any eye products that you dispense or use. If the certification is not present, exercise caution and skepticism.
- 2. Consult a Friend: Before prescribing or dispensing any new eye product, consult your reliable pharmacy or colleague. They can recommend safe or alternate options for your needs.
- 3. Report Suspected Issues: If you suspect any issues with the eye products, report it to the FDA’s MedWatch Program. This helps in monitoring and addressing safety concerns.
- 4. Be Skeptical of “Miracle” Claims: Beware of using products that promise beyond reason. If it sounds too good to be true, it probably is.
Conclusion:
The well-being of both your patient's eyes and your own is invaluable and deserves utmost care and attention. Thisdecisive action by the FDA stands as an imperative component in elevating patient awareness of the harmful effects of unregulated treatments. By highlighting the violations, clarifying regulatory status, and promoting transparency, the FDA letter gives the public the information needed to make informed decisions about different treatment avenues for their eye conditions. As the industry continues to grow, the FDA needs to work to make sure patient safety is the highest priority to help avoid any unnecessary complications. Always trust in regulated and approved treatments, and always seek help and guidance when in doubt.
References:
Administration, F. a. D. (2023). FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products
Region, a. S. F. (2022). Ophthalmic Drugs Market Size, Share & Trends Analysis Report by Drug Class, by Disease (Dry Eye, Glaucoma), by Dosage Form, by Route of Administration, by Product Type (Prescription, OTC), by Region, and Segment Forecasts, 2022-2030. Retrieved September 29 from https://www.researchandmarkets.com/reports/4429696/ophthalmic-drugs-market-size-share-and-trends
Waszczykowska, A., Zyro, D., Ochocki, J., & Jurowski, P. (2021). Clinical Application and Efficacy of Silver Drug in Ophthalmology: A Literature Review and New Formulation of EYE Drops with Drug Silver (I) Complex of Metronidazole with Improved Dosage Form. Biomedicines, 9(2). https://doi.org/10.3390/biomedicines9020210
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