FDA 发布眼药水安全须知：眼用药品绕过人体天然防御，存在感染与失明风险并涉及近期 OTC 眼药水召回
What You Should Know about Eye Drops
FDA 发布眼药水安全须知，指出眼用药品因绕过人体部分天然防御而对使用者构成更高伤害风险，须无菌并依靠防腐剂防止微生物污染。FDA 称近期多起 OTC 眼药水召回源于产品污染风险，涉及感染、部分视力丧失和失明报告，并提醒勿使用宣称治疗青光眼、白内障等严重眼病的 OTC 产品及含银硫酸盐、MSM、蜂蜜、CBD 等成分的产品。
Eye drops bypass some of the body’s natural defenses, posing a heightened risk of harm to users
Report issues to FDA
Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Preservatives play a crucial role in preventing microbial contamination, extending shelf life, and ensuring the safety of many eye drop products, especially eye drop products in multi-dose containers. Eye drops are available by prescription or sold as over-the-counter (OTC) products.
There have been several recent safety recalls related to OTC eye drop products. These recalls resulted from various safety concerns, including reports of infections, partial loss of vision, and blindness. The recalls were due to product contamination risks.
Facilities manufacturing eye drops marketed in the U.S. are required to be registered with FDA. FDA actively monitors eye drops in the marketplace by conducting surveillance, including sampling and testing products on the market, and monitoring side effects. FDA uses a risk-based approach to identify facilities for inspection. FDA may recommend voluntary recalls to remove products from the market. We will continue to update the public about new concerns or information.
Consumer Tips
- Wash your hands with soap and water before using eye drops, and do not touch the tip of the eye drop bottle to your hands, your eyes, your clothing, or any other surface to avoid contamination.
- Stop using eye drops if you experience any issue while using the products, such as discharge from the eye, pain, changes in vision or discomfort.
- If you experience any unexpected side effects while using eye drops, talk to your doctor and report the issue to FDA.
- Do not use ophthalmic products that:
- Are marketed as OTC products to treat serious eye conditions such as glaucoma, cataracts, retinopathy, or macular degeneration. There are no OTC treatments for these conditions.
- Are labeled as homeopathic, as these products should not be marketed and are not approved by FDA.
- Claim to change the color of your iris (the colored part of the eye). There are no FDA-approved eye drops to change eye color.
- Some unapproved products contain ingredients that are not appropriate for use in the eye, such as:
- Silver sulfate or argentum, which can permanently change the white color of your eyes.
- Methylsulfonylmethane (MSM) as an active ingredient. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.
- Honey, which can cause a burning sensation in the eye.
- Cannabidiol (CBD), which is found in cannabis. There are no legally marketed ophthalmic drugs that contain CBD as an active ingredient.
- Carefully review the label of your eye products to ensure the product does not include these ingredients.
- Review the alerts and warnings about eye drops below, and check if your eye drops are part of a warning or recall.
- Talk to a health care professional about safe and effective treatments for your eye condition.
How to Report Issues
FDA encourages health care professionals and consumers to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
来源：FDA 官方药品与生物制品信息 · fda.gov